Quick answers
- What is Norethindrone and ethinyl estradiol used for?
- The FDA-approved label (Nortrel 28 Day, Teva Pharmaceuticals USA, Inc., December 1, 2021) says: “Nortrel 1/35 and Nortrel 0.5/35 Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Norethindrone and ethinyl estradiol have a boxed warning?
- Yes. The FDA label for Nortrel 28 Day has a boxed warning (“WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Norethindrone and ethinyl estradiol?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Norethindrone and ethinyl estradiol been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started January 25, 2024 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Norethindrone and ethinyl estradiol?
- 1 company lists prescription products of Norethindrone and ethinyl estradiol in the FDA NDC Directory, including Teva Pharmaceuticals USA, Inc..
What Norethindrone and ethinyl estradiol is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Nortrel 1/35 and Nortrel 0.5/35 Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table 1 lists the typical accidental pregnancy rates for users of combined oral contraceptives and other methods of contraception. …
— FDA label: Nortrel 28 Day, Teva Pharmaceuticals USA, Inc., effective December 1, 2021. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
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. Its heading: WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING
. Read it on the full label →
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Nortrel 21 Day |
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 |
|---|---|---|
| ethinyl estradiol 0.035 mg · norethindrone 1 mg tablet | Generic | $0.3730 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.
- Teva Pharmaceuticals USA, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (1)
- ANDA072693Barr · February 28, 1992
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 25, 2024 · Class III · Ongoing · D-0321-2024
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, — Teva Pharmaceuticals USA, 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Nortrel 28 Day, Teva Pharmaceuticals USA, Inc., effective December 1, 2021; 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 →