FDA Orange Book
Generic for Axid
Axid contains nizatidine. 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 Axid is nizatidine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Axid products the Orange Book lists.
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Axid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 150MG | Discontinued | None | 3 | AB |
| capsule, oral | 300MG | Discontinued | None | 3 | AB |
| solution, oral | 15MG/ML | Discontinued | None | 0 | None |
NDA 019508, 021494, held by SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic nizatidine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| EPIC PHARMA LLC | 076178 | AB (A-rated, therapeutically equivalent) | July 5, 2002 | 150MG, 300MG |
| WATSON LABORATORIES INC | 075616 | AB (A-rated, therapeutically equivalent) | July 9, 2002 | 150MG, 300MG |
| DR REDDYS LABORATORIES LTD | 077314 | AB (A-rated, therapeutically equivalent) | September 15, 2005 | 150MG, 300MG |
Questions
Is there a generic for Axid?
Yes. The generic name for Axid is nizatidine. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 3 Axid products the Orange Book lists.
What is the generic name for Axid?
The active ingredient in Axid is nizatidine, 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.