Quick answers
- What is Terconazole used for?
- The FDA-approved label (Terconazole Vaginal Cream 0.8%, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, January 28, 2026) says: “Terconazole Vaginal Cream, is indicated for the treatment of vulvovaginal candidiasis in adult females. Terconazole Vaginal Cream is an azole antifungal indicated for the treatment of vulvovaginal candidiasis in adult females.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Terconazole have a boxed warning?
- No. None of the 12 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Terconazole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Terconazole been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started January 26, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Terconazole?
- 6 companies list prescription products of Terconazole in the FDA NDC Directory, including A-S Medication Solutions, Sun Pharmaceutical Industries, Inc. and E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC.
What Terconazole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Terconazole Vaginal Cream, is indicated for the treatment of vulvovaginal candidiasis in adult females. Terconazole Vaginal Cream is an azole antifungal indicated for the treatment of vulvovaginal candidiasis in adult females.
— FDA label: Terconazole Vaginal Cream 0.8%, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026. Read the full label on DailyMed →
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.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 12 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Cream · Suppository |
|---|---|
| Route | Vaginal |
| Prescription products | 12 in the FDA NDC Directory |
| Brand names | Terconazole Vaginal Cream 0.8% |
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 |
|---|---|---|
| terconazole 0.4% cream | Generic | $0.5557 per gram |
| terconazole 0.8% cream | Generic | $0.9784 per gram |
| terconazole 80 mg suppository | Generic | $18.87 per suppository |
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.
- A-S Medication Solutions4 products
- Sun Pharmaceutical Industries, Inc.3 products
- E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC2 products
- Padagis Israel Pharmaceuticals Ltd1 product
- NuCare Pharmaceuticals, Inc.1 product
- Cosette Pharmaceuticals, Inc.1 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 |
|---|---|---|---|
| NDA021735 TERCONAZOLE | Fougera | October 1, 2004 | 3, latest August 22, 2025 2025: Labeling · 2013: Manufacturing (CMC) · 2010: Labeling |
Generic approvals (5)
- ANDA075953Sun Pharma Canada · April 6, 2004
- ANDA076043Sun Pharma Canada · January 19, 2005
- ANDA076712Fougera Pharms · February 18, 2005
- ANDA077149Padagis Israel · March 17, 2006
- ANDA077553Sun Pharma Canada · March 9, 2007
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 26, 2022 · Class II · Terminated · D-0198-2024
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by: Cosette Pharmaceuticals, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. NDC: 0713-0552-73 — CARDINAL HEALTHCARE
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
| RxCUI (RxNorm) | 198245, 313226, 313227 |
|---|---|
| SPL set ID of the quoted label | f59448bd-f730-46d2-a785-c2d6205579ff |
| FDA labels (SPL) | 12 |
| FDA applications | NDA021735, 5 ANDA |
| Active ingredients (FDA) | TERCONAZOLE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Terconazole Vaginal Cream 0.8%, E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC, effective January 28, 2026; 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 →