FDA Orange Book
Generic for Tolectin DS
Tolectin DS contains tolmetin. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Tolectin DS is tolmetin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Tolectin DS products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 400MG BASE | Discontinued | None | 1 | None |
NDA 018084, held by ORTHO MCNEIL JANSSEN PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic tolmetin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RISING PHARMA HOLDINGS INC | 073393 | None (No TE code listed) | May 27, 1993 | EQ 400MG BASE |
Questions
Is there a generic for Tolectin DS?
Yes. The generic name for Tolectin DS is tolmetin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Tolectin DS?
The active ingredient in Tolectin DS is tolmetin, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.