FDA Orange Book
Generic for Rimifon
Rimifon contains isoniazid. 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 Rimifon is isoniazid. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 2 of the 3 Rimifon products the Orange Book lists.
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Rimifon products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 100MG/ML | Discontinued | None | 1 | None |
| injectable, injection | 25MG/ML | Discontinued | None | 0 | None |
| syrup, oral | 50MG/5ML | Discontinued | None | 2 | AA |
NDA 008420, held by HOFFMANN LA ROCHE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic isoniazid
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CMP PHARMA INC | 088235 | AA (A-rated, therapeutically equivalent) | November 10, 1983 | 50MG/5ML |
| CHARTWELL RX SCIENCES LLC | 081118 | AA (A-rated, therapeutically equivalent) | July 21, 1997 | 50MG/5ML |
| SANDOZ INC | 040648 | None (No TE code listed) | July 5, 2005 | 100MG/ML |
Questions
Is there a generic for Rimifon?
Yes. The generic name for Rimifon is isoniazid. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 2 of the 3 Rimifon products the Orange Book lists.
What is the generic name for Rimifon?
The active ingredient in Rimifon is isoniazid, 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.