Quick answers
- What is Estradiol and norethindrone acetate used for?
- The FDA-approved label (Lopreeza, Amneal Pharmaceuticals NY LLC, January 16, 2025) says: “Lopreeza is indicated for: Lopreeza is an estrogen and progestin combination indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitations of Use …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Estradiol and norethindrone acetate?
- The “Adverse Reactions” section of the FDA label (Lopreeza, Amneal Pharmaceuticals NY LLC, January 16, 2025) begins: “The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.1)] Malignant Neoplasms [see Boxed Warning, Warnings and Precautions (5.2)] The most common adverse reactions (incidence ≥ 5 percent) with Lopreeza are: back pain, headache, pain in the extremity, nausea, diarrhea, gastroenteritis, insomnia, emotional lability, upper respiratory tract infection, sinusitis, nasopharyngitis, weight increase, breast pain, post-menopausal bleeding, uterine fibroid vaginal hemorrhage, ovarian cyst, endometrial thickening, viral infection, moniliasis genital, and accidental injury.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Estradiol and norethindrone acetate?
- The “Drug Interactions” section of the FDA label (Lopreeza, Amneal Pharmaceuticals NY LLC, January 16, 2025) begins: “Co-administration of estradiol with norethindrone acetate did not elicit any apparent influence on the pharmacokinetics of norethindrone acetate. Similarly, no relevant interaction of norethindrone acetate on the pharmacokinetics of estradiol was found within the NETA dose range investigated in a single dose study. Estradiol In-vitro and in-vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4).” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Estradiol and norethindrone acetate have a boxed warning?
- Yes. The FDA label for Lopreeza has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Estradiol and norethindrone acetate?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Estradiol and norethindrone acetate been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started January 7, 2022 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Estradiol and norethindrone acetate?
- 10 companies list prescription products of Estradiol and norethindrone acetate in the FDA NDC Directory, including Amneal Pharmaceuticals NY LLC, A-S Medication Solutions and Xiromed, LLC.
What Estradiol and norethindrone acetate is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Lopreeza is indicated for: Lopreeza is an estrogen and progestin combination indicated in a woman with a uterus for: Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Limitations of Use …
— FDA label: Lopreeza, Amneal Pharmaceuticals NY LLC, effective January 16, 2025. Read the full label on DailyMed →
Label quoted: the one for the most common form (tablet, film coated, oral), Lopreeza, Amneal Pharmaceuticals NY LLC; it covers 2 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 12 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
12 of 12 FDA labels for this medicine have a boxed warning.
Estradiol and norethindrone acetate boxed warning: what the label says
Quoted from the boxed warning of the FDA-approved label.
WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, and ENDOMETRIAL CANCER Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogen (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions (5.1), and Clinical Studies (14.5)].
Read more of this section
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.3), Use in Specific Populations (8.5), and Clinical Studies (14.6)]. Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3), and Clinical Studies (14.5, 14.6)]. Breast Cancer The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer [see Warnings and Precautions (5.2), and Clinical Studies (14.5)]. Only daily oral 0.625 mg CE and 2.5 mg MPA were studied in the estrogen plus progestin substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile. Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. Estrogen-Alone Therapy Endometrial Cancer There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions (5.2)]. Cardiovascular Disorders and Probable Dementia The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg)-alone, relative to placebo [see Warnings and Precautions (5.1), and Clinical Studies (14.5)]. The WHIMS estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo.
— FDA label: Lopreeza, Amneal Pharmaceuticals NY LLC, effective January 16, 2025. This is part of the section. Read the full label on DailyMed →
Estradiol and norethindrone acetate side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following serious adverse reactions are discussed elsewhere in the labeling: Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.1)] Malignant Neoplasms [see Boxed Warning, Warnings and Precautions (5.2)] The most common adverse reactions (incidence ≥ 5 percent) with Lopreeza are: back pain, headache, pain in the extremity, nausea, diarrhea, gastroenteritis, insomnia, emotional lability, upper respiratory tract infection, sinusitis, nasopharyngitis, weight increase, breast pain, post-menopausal bleeding, uterine fibroid vaginal hemorrhage, ovarian cyst, endometrial thickening, viral infection, moniliasis genital, and accidental injury.
Read more of this section
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse reactions reported with Lopreeza 1 mg/0.5 mg by investigators during clinical trials regardless of causality assessment are shown in Table 1. TABLE 1 ALL TREATMENT-EMERGENT ADVERSE REACTIONS REGARDLESS OF RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5 PERCENT WITH LOPREEZA 1 MG/0.5 MG Endometrial Hyperplasia Study (12-Months) Vasomotor Symptoms Study (3-Months) Osteoporosis Study (2-Years) Lopreeza 1 mg/0.5 mg 1 mg E 2 Lopreeza 1 mg/0.5 mg Placebo Lopreeza 1 mg/0.5 mg Placebo (n=295) (n=296) (n=29) (n=34) (n=47) (n=48) Body as a Whole Back Pain 6% 5% 3% 3% 6% 4% Headache 16% 16% 17% 18% 11% 6% Digestive System Nausea 3% 5% 10% 0% 11% 0% Gastroenteritis 2% 2% 0% 0% 6% 4% Nervous System Insomnia 6% 4% 3% 3% 0% 8% Emotional Lability 1% 1% 0% 0% 6% 0% Respiratory System Upper Respiratory Tract Infection 18% 15% 10% 6% 15% 19% Sinusitis 7% 11% 7% 0% 15% 10% Metabolic and Nutritional Weight Increase 0% 0% 0% 0% 9% 6% Urogenital System Breast Pain 24% 10% 21% 0% 17% 8% Post-Menopausal Bleeding 5% 15% 10% 3% 11% 0% Uterine Fibroid 5% 4% 0% 0% 4% 8% Ovarian Cyst 3% 2% 7% 0% 0% 8% Resistance Mechanism Infection Viral 4% 6% 0% 3% 6% 6% Moniliasis Genital 4% 7% 0% 0% 6% 0% Secondary Terms Injury Accidental 4% 3% 3% 0% 17%* 4%* Other Events 2% 3% 3% 0% 6% 4% * including one upper extremity fracture in each group Adverse reactions reported with Lopreeza 0.5 mg/0.1 mg by investigators during clinical trials regardless of causality assessment are shown in Table 2. TABLE 2 ALL TREATMENT-EMERGENT ADVERSE REACTIONS REGARDLESS OF RELATIONSHIP REPORTED AT A FREQUENCY OF ≥ 5 PERCENT WITH LOPREEZA 0.5 MG/0.1 MG Lopreeza 0.5 mg/0.1 mg Placebo (n=194) (n=200) Body as a Whole Back Pain 10% 4% Headache 22% 19% Pain in extremity 5% 4% Digestive System Nausea 5% 4% Diarrhea 6% 6% Respiratory System Nasopharyngitis 21% 18% Urogenital System Endometrial thickening 10% 4% Vaginal hemorrhage 26% 12% 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Lopreeza. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
— FDA label: Lopreeza, Amneal Pharmaceuticals NY LLC, effective January 16, 2025. This is part of the section. Read the full label on DailyMed →
Estradiol and norethindrone acetate drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Co-administration of estradiol with norethindrone acetate did not elicit any apparent influence on the pharmacokinetics of norethindrone acetate. Similarly, no relevant interaction of norethindrone acetate on the pharmacokinetics of estradiol was found within the NETA dose range investigated in a single dose study. Estradiol In-vitro and in-vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4).
Read more of this section
Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John’s wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine, and rifampin may reduce plasma concentrations of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase plasma concentrations of estrogens and result in adverse reactions. Norethindrone Acetate Drugs or herbal products that induce or inhibit cytochrome P-450 enzymes, including CYP3A4, may decrease or increase the serum concentrations of norethindrone. Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism and decrease or increase the estrogen plasma concentration. (7)
— FDA label: Lopreeza, Amneal Pharmaceuticals NY LLC, effective January 16, 2025. Read the full label on DailyMed →
Estradiol and norethindrone acetate dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Use estrogen-alone, or in combination with a progestogen, at the lowest effective dose and the shortest duration consistent with treatment goals and risks for the individual woman. Reevaluate postmenopausal women periodically as clinically appropriate to determine whether treatment is still necessary.
Read more of this section
Take a single Lopreeza 1 mg/0.5 mg or 0.5 mg/0.1 mg tablet orally once daily for the Treatment of Moderate to severe Vasomotor Symptoms due to Menopause and for the Prevention of Postmenopausal Osteoporosis (2.1, 2.3) Lopreeza 1 mg/0.5 mg tablets are taken orally once daily for the Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause (2.2) 2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Take a single Lopreeza tablet orally once daily for the treatment of moderate to severe vasomotor symptoms due to menopause. Lopreeza 1 mg/0.5 mg Lopreeza 0.5 mg/0.1 mg 2.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause Take a single Lopreeza tablet orally once daily for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause. Lopreeza 1 mg/0.5 mg 2.3 Prevention of Postmenopausal Osteoporosis Take a single Lopreeza tablet orally once daily for the prevention of postmenopausal osteoporosis. Lopreeza 1 mg/0.5 mg Lopreeza 0.5 mg/0.1 mg
— FDA label: Lopreeza, Amneal Pharmaceuticals NY LLC, effective January 16, 2025. Read the full label on DailyMed →
Estradiol and norethindrone acetate in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary Lopreeza is not indicated for use in pregnancy. There are no data with the use of Lopreeza in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalities and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogen and progestins) before conception or during early pregnancy.
Read more of this section
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
— FDA label: Lopreeza, Amneal Pharmaceuticals NY LLC, effective January 16, 2025. Read the full label on DailyMed →
When Estradiol and norethindrone acetate should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Lopreeza is contraindicated in women with any of the following conditions: Undiagnosed abnormal genital bleeding [see Warnings and Precautions (5.2)] Breast cancer or history of breast cancer [see Warnings and Precautions (5.2)] Estrogen-dependent neoplasia [see Warnings and Precautions (5.2)] Active DVT, PE, or history of these conditions [see Warnings and Precautions (5.1)] Active arterial thromboembolic disease (for example, stroke and MI), or a history of these …
— FDA label: Lopreeza, Amneal Pharmaceuticals NY LLC, effective January 16, 2025. This is part of the section. Read the full label on DailyMed →
Estradiol and norethindrone acetate overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Overdosage of estrogen plus progestogen may cause nausea, vomiting, breast tenderness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of Lopreeza therapy with institution of appropriate symptomatic care.
— FDA label: Lopreeza, Amneal Pharmaceuticals NY LLC, effective January 16, 2025. Read the full label on DailyMed →
Forms and how it is given
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| estradiol 0.05 mg/d · norethindrone acetate 0.14 mg/d patch, extended release | Brand: CombiPatch (estradiol/norethindrone acetate transdermal system) | $31.81 per patch |
| estradiol 0.05 mg/d · norethindrone acetate 0.25 mg/d patch, extended release | Brand: CombiPatch (estradiol/norethindrone acetate transdermal system) | $31.79 per patch |
| estradiol 0.5 mg · norethindrone acetate 0.1 mg tablet | Generic | $0.7123 per tablet |
| estradiol 0.5 mg · norethindrone acetate 0.1 mg tablet, film coated | Generic | $0.7123 per tablet |
| estradiol 1 mg · norethindrone acetate 0.5 mg tablet | Generic | $0.5972 per tablet |
| estradiol 1 mg · norethindrone acetate 0.5 mg tablet, film coated | Generic | $0.5972 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Amneal Pharmaceuticals NY LLC4 products
- A-S Medication Solutions2 products
- Xiromed, LLC2 products
- Breckenridge Pharmaceutical, Inc.2 products
- Noven Therapeutics, LLC2 products
- Aurobindo Pharma Limited2 products
- Amneal Pharmaceuticals LLC2 products
- Ingenus Pharmaceuticals, LLC2 products
- Teva Pharmaceuticals USA, Inc.1 product
- Naari Pte. Limited1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA020870 COMBIPATCH | Noven Pharms Inc | August 7, 1998 | 15, latest February 15, 2024 2024: Labeling · 2017: Labeling · 2015: Manufacturing (CMC) |
| NDA020907 ACTIVELLA | Amneal | November 18, 1998 | 17, latest February 15, 2024 2024: Labeling · 2021: Labeling · 2021: Labeling |
Generic approvals (6)
- ANDA078324Breckenridge Pharm · April 17, 2008
- ANDA079193Barr · May 11, 2010
- ANDA207261Xiromed · February 10, 2017
- ANDA210233Naari Pte · February 28, 2018
- ANDA210612Novast Labs · April 3, 2019
- ANDA214729Aurobindo Pharma Ltd · June 30, 2023
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
January 7, 2022 · Class III · Terminated · D-0522-2022
Mislabeling
Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc — Teva Pharmaceuticals USA
-
January 7, 2022 · Class III · Terminated · D-0521-2022
Mislabeling
Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA In — Teva Pharmaceuticals USA
-
July 30, 2021 · Class II · Ongoing · D-0724-2021
Failed Stability Specifications; out of specification for shear.
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, — Noven Pharmaceuticals Inc
-
July 30, 2021 · Class II · Ongoing · D-0725-2021
Failed Stability Specifications; out of specification for shear.
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, — Noven Pharmaceuticals Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
- Latest FDA drug recallsAll medicines, newest first
- LopreezaBrand page: products, maker and price
- ActivellaBrand page: products, maker and price
- EtyqaBrand page: products, maker and price
- AbigaleBrand page: products, maker and price
- OsteoporosisCondition named on the label: hospitals that treat it
- Amneal Pharmaceuticals NY LLCMaker or distributor
- A-S Medication SolutionsMaker or distributor
- Xiromed, LLCMaker or distributor
- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Lopreeza, Amneal Pharmaceuticals NY LLC, effective January 16, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →