Quick answers
- What is Tolmetin sodium used for?
- The FDA-approved label (Tolectin, Poly Pharmaceuticals, Inc., December 30, 2025) says: “Carefully consider the potential benefits and risks of TOLECTIN tablets, USP and other treatment options before deciding to use TOLECTIN tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). TOLECTIN tablets are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tolmetin sodium have a boxed warning?
- Yes. The FDA label for Tolectin has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Tolmetin sodium?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tolmetin sodium been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Tolmetin sodium?
- 5 companies list prescription products of Tolmetin sodium in the FDA NDC Directory, including Atland Pharmaceuticals, LLC, Lifsa Drugs LLC and Galt Pharmaceuticals, LLC.
What Tolmetin sodium is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Carefully consider the potential benefits and risks of TOLECTIN tablets, USP and other treatment options before deciding to use TOLECTIN tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). TOLECTIN tablets are indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis. …
— FDA label: Tolectin, Poly Pharmaceuticals, Inc., effective December 30, 2025. Read the full label on DailyMed →
The FDA has 6 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 →
6 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet · Capsule |
|---|---|
| Route | Oral |
| Prescription products | 6 in the FDA NDC Directory |
| Brand names | Tolectin |
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.
- Atland Pharmaceuticals, LLC2 products
- Lifsa Drugs LLC1 product
- Galt Pharmaceuticals, LLC1 product
- Chartwell RX, LLC1 product
- Poly Pharmaceuticals, Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (3)
- ANDA073588Chartwell Rx · July 31, 1992
- ANDA073393Rising · May 27, 1993
- ANDA074473Rising · August 30, 1994
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) | 198295, 198296, 198297, 208048 |
|---|---|
| SPL set ID of the quoted label | 15467b19-e43a-5be9-e063-6294a90a3cca |
| FDA labels (SPL) | 6 |
| FDA applications | 3 ANDA |
| Active ingredients (FDA) | TOLMETIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tolectin, Poly Pharmaceuticals, Inc., effective December 30, 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 →