Quick answers
- What is Tinidazole used for?
- The FDA-approved label (Tindamax, Mission Pharmacal Company, December 27, 2021) says: “INDICATIONS AND USAGE 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tinidazole have a boxed warning?
- Yes. The FDA label for Tindamax has a boxed warning (“WARNING: POTENTIAL RISK FOR CARCINOGENICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Tinidazole?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tinidazole been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tinidazole?
- 7 companies list prescription products of Tinidazole in the FDA NDC Directory, including Rising Pharma Holdings, Inc., Lupin Pharmaceuticals, Inc. and Mission Pharmacal Company.
What Tinidazole is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
INDICATIONS AND USAGE 1.1 Trichomoniasis Tinidazole is indicated for the treatment of trichomoniasis caused by Trichomonas vaginalis. The organism should be identified by appropriate diagnostic procedures. Because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, partners of infected patients should be treated simultaneously in order to prevent re-infection […]. …
— FDA label: Tindamax, Mission Pharmacal Company, effective December 27, 2021. Read the full label on DailyMed →
The FDA has 8 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.
This label has a boxed warning. Its heading: WARNING: POTENTIAL RISK FOR CARCINOGENICITY
. Read it on the full label →
8 of 8 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 13 in the FDA NDC Directory |
| Brand names | Tindazole, Tindamax |
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 |
|---|---|---|
| tinidazole 250 mg tablet | Generic | $1.43 per tablet |
| tinidazole 250 mg tablet, film coated | Generic | $1.43 per tablet |
| tinidazole 500 mg tablet | Generic | $2.47 per tablet |
| tinidazole 500 mg tablet, film coated | Generic | $2.47 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.
- Rising Pharma Holdings, Inc.2 products
- Lupin Pharmaceuticals, Inc.2 products
- Mission Pharmacal Company2 products
- Chartwell RX, LLC2 products
- Remedyrepack Inc.2 products
- Edenbridge Pharmaceuticals LLC.2 products
- BioComp Pharma, 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 |
|---|---|---|---|
| NDA021618 TINDAMAX | Mission Pharma | May 17, 2004 | 5, latest December 15, 2021 2021: Labeling · 2020: Labeling · 2019: Labeling |
Generic approvals (3)
- ANDA202044Chartwell Rx · April 30, 2012
- ANDA202489Unique · October 9, 2013
- ANDA203808Edenbridge Pharms · August 4, 2015
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 199519, 477234, 539809, 539811 |
|---|---|
| SPL set ID of the quoted label | a0d01539-8413-4703-94cc-d221918630a1 |
| FDA labels (SPL) | 8 |
| FDA applications | NDA021618, 3 ANDA |
| Active ingredients (FDA) | TINIDAZOLE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tindamax, Mission Pharmacal Company, effective December 27, 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 →