FDA Orange Book
Generic for Nydrazid
Nydrazid 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 Nydrazid is isoniazid. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
Run it in Rivvi
Map Nydrazid and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Nydrazid 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 |
| tablet, oral | 100MG | Discontinued | None | 2 | AA |
NDA 008662, 008392, held by SANDOZ 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 |
|---|---|---|---|---|
| OMNIVIUM PHARMACEUTICALS LLC | 040090 | AA (A-rated, therapeutically equivalent) | June 26, 1997 | 100MG |
| SANDOZ INC | 040648 | None (No TE code listed) | July 5, 2005 | 100MG/ML |
| THEPHARMANETWORK LLC | 202610 | AA (A-rated, therapeutically equivalent) | October 29, 2014 | 100MG |
Questions
Is there a generic for Nydrazid?
Yes. The generic name for Nydrazid is isoniazid. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.
What is the generic name for Nydrazid?
The active ingredient in Nydrazid 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.