Quick answers
- What is Trimethoprim used for?
- The FDA-approved label (Trimethoprim, Dr. Reddy's Labratories Inc., January 26, 2024) says: “To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Trimethoprim have a boxed warning?
- No. None of the 5 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Trimethoprim?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Trimethoprim been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Trimethoprim?
- 5 companies list prescription products of Trimethoprim in the FDA NDC Directory, including Lupin Pharmaceuticals, Inc., Novel Laboratories, Inc. and Novitium Pharma LLC.
What Trimethoprim is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of trimethoprim tablets, USP and other antibacterial drugs, trimethoprim tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. …
— FDA label: Trimethoprim, Dr. Reddy's Labratories Inc., effective January 26, 2024. Read the full label on DailyMed →
The FDA has 5 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 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet |
|---|---|
| Route | Oral |
| Prescription products | 5 in the FDA NDC Directory |
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 |
|---|---|---|
| trimethoprim 100 mg tablet | Generic | $1.39 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.
- Lupin Pharmaceuticals, Inc.1 product
- Novel Laboratories, Inc.1 product
- Novitium Pharma LLC1 product
- Golden State Medical Supply, Inc.1 product
- Dr. Reddy's Labratories 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 |
|---|---|---|---|
| NDA018679 TRIMETHOPRIM | DR Reddys Labs SA | July 30, 1982 | 30, latest August 11, 2016 2016: Manufacturing (CMC) · 2016: Labeling · 2012: Labeling |
Generic approvals (2)
- ANDA091437Novel Labs Inc · June 15, 2011
- ANDA216393Novitium Pharma · October 28, 2022
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) | 198332 |
|---|---|
| SPL set ID of the quoted label | 73ccebc1-7412-2424-d62c-a5180ec52d81 |
| FDA labels (SPL) | 5 |
| FDA applications | NDA018679, 2 ANDA |
| Active ingredients (FDA) | TRIMETHOPRIM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Trimethoprim, Dr. Reddy's Labratories Inc., effective January 26, 2024; 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 →