FDA Orange Book
Generic for Tagamet
Tagamet contains cimetidine. 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 Tagamet is cimetidine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 5 of the 6 Tagamet products the Orange Book lists.
Run it in Rivvi
Map Tagamet 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.
Tagamet products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 300MG BASE/2ML | Discontinued | None | 0 | None |
| solution, oral | EQ 300MG BASE/5ML | Discontinued | None | 2 | AA |
| tablet, oral | 200MG | Discontinued | None | 5 | AB |
| tablet, oral | 300MG | Discontinued | None | 5 | AB |
| tablet, oral | 400MG | Discontinued | None | 5 | AB |
| tablet, oral | 800MG | Discontinued | None | 5 | AB |
NDA 017939, 017924, 017920, held by GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cimetidine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| CHARTWELL MOLECULES LLC | 074329 | AB (A-rated, therapeutically equivalent) | May 17, 1994 | 200MG, 300MG, 400MG, 800MG |
| MYLAN PHARMACEUTICALS INC | 074246 | AB (A-rated, therapeutically equivalent) | May 17, 1994 | 200MG, 300MG, 400MG, 800MG |
| TEVA PHARMACEUTICALS USA INC | 074151 | AB (A-rated, therapeutically equivalent) | May 17, 1994 | 200MG, 300MG, 400MG |
| TEVA PHARMACEUTICALS USA INC | 074463 | AB (A-rated, therapeutically equivalent) | May 17, 1994 | 800MG |
| CHARTWELL MOLECULAR HOLDINGS LLC | 074251 | AA (A-rated, therapeutically equivalent) | December 22, 1994 | EQ 300MG BASE/5ML |
| PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC | 074664 | AA (A-rated, therapeutically equivalent) | October 28, 1997 | EQ 300MG BASE/5ML |
| BIONPHARMA INC | 218220 | AB (A-rated, therapeutically equivalent) | November 7, 2024 | 200MG, 300MG, 400MG, 800MG |
| AUROBINDO PHARMA LTD | 218997 | AB (A-rated, therapeutically equivalent) | November 12, 2024 | 200MG, 300MG, 400MG, 800MG |
Questions
Is there a generic for Tagamet?
Yes. The generic name for Tagamet is cimetidine. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB. Generics match 5 of the 6 Tagamet products the Orange Book lists.
What is the generic name for Tagamet?
The active ingredient in Tagamet is cimetidine, 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.