FDA Orange Book
Generic for Pepcid
Pepcid contains famotidine. 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 Pepcid is famotidine. 33 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
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Pepcid products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 40MG/5ML | Discontinued | None | 18 | AB |
| injectable, injection | 10MG/ML | Discontinued | None | 11 | AP |
| tablet, oral | 20MG | Discontinued | None | 17 | AB |
| tablet, oral | 40MG | Discontinued | None | 17 | AB |
NDA 019527, 019510, 019462, held by SALIX PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic famotidine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| FRESENIUS KABI USA LLC | 075709 | AP (A-rated, therapeutically equivalent) | April 16, 2001 | 10MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 075488 | AP (A-rated, therapeutically equivalent) | April 16, 2001 | 10MG/ML |
| SAGENT PHARMACEUTICALS | 075651 | AP (A-rated, therapeutically equivalent) | April 16, 2001 | 10MG/ML |
| SAGENT PHARMACEUTICALS | 075684 | AP (A-rated, therapeutically equivalent) | April 16, 2001 | 10MG/ML |
| FRESENIUS KABI USA LLC | 075813 | AP (A-rated, therapeutically equivalent) | April 16, 2001 | 10MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 075486 | AP (A-rated, therapeutically equivalent) | April 16, 2001 | 10MG/ML |
| SAGENT PHARMACEUTICALS | 075622 | AP (A-rated, therapeutically equivalent) | April 16, 2001 | 10MG/ML |
| CARLSBAD TECHNOLOGY INC | 075805 | AB (A-rated, therapeutically equivalent) | April 16, 2001 | 20MG, 40MG |
| CHARTWELL RX SCIENCES LLC | 075786 | AB (A-rated, therapeutically equivalent) | April 16, 2001 | 20MG, 40MG |
| DR REDDYS LABORATORIES LTD | 075718 | AB (A-rated, therapeutically equivalent) | April 16, 2001 | 20MG, 40MG |
| IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA | 075511 | AB (A-rated, therapeutically equivalent) | April 16, 2001 | 20MG, 40MG |
| MANKIND PHARMA LTD | 075302 | AB (A-rated, therapeutically equivalent) | April 16, 2001 | 20MG, 40MG |
| RISING PHARMA HOLDING INC | 075704 | AB (A-rated, therapeutically equivalent) | April 16, 2001 | 20MG, 40MG |
| SAGENT PHARMACEUTICALS | 075825 | AP (A-rated, therapeutically equivalent) | April 17, 2001 | 10MG/ML |
| MYLAN LABORATORIES LTD | 078641 | AP (A-rated, therapeutically equivalent) | June 25, 2008 | 10MG/ML |
| MYLAN LABORATORIES LTD | 078642 | AP (A-rated, therapeutically equivalent) | June 25, 2008 | 10MG/ML |
| ALEMBIC PHARMACEUTICALS LTD | 078916 | AB (A-rated, therapeutically equivalent) | May 22, 2009 | 20MG, 40MG |
| NAVINTA LLC | 091020 | AB (A-rated, therapeutically equivalent) | May 27, 2010 | 40MG/5ML |
| LUPIN LTD | 090440 | AB (A-rated, therapeutically equivalent) | June 29, 2010 | 40MG/5ML |
| NOVEL LABORATORIES INC | 201695 | AB (A-rated, therapeutically equivalent) | December 17, 2012 | 40MG/5ML |
| NOVITIUM PHARMA LLC | 201995 | AB (A-rated, therapeutically equivalent) | May 30, 2014 | 40MG/5ML |
| AUROBINDO PHARMA LTD | 206530 | AB (A-rated, therapeutically equivalent) | December 22, 2015 | 20MG, 40MG |
| NOVITIUM PHARMA LLC | 215043 | AB (A-rated, therapeutically equivalent) | April 20, 2021 | 40MG/5ML |
| ASCENT PHARMACEUTICALS INC | 215689 | AB (A-rated, therapeutically equivalent) | October 15, 2021 | 20MG, 40MG |
| ANNORA PHARMA PRIVATE LTD | 215767 | AB (A-rated, therapeutically equivalent) | November 4, 2021 | 20MG, 40MG |
| VKT PHARMA PRIVATE LTD | 215630 | AB (A-rated, therapeutically equivalent) | January 7, 2022 | 20MG, 40MG |
| ZYDUS PHARMACEUTICALS USA INC | 216441 | AB (A-rated, therapeutically equivalent) | June 3, 2022 | 20MG, 40MG |
| AMNEAL PHARMACEUTICALS LLC | 216427 | AB (A-rated, therapeutically equivalent) | August 4, 2022 | 40MG/5ML |
| ALKEM LABORATORIES LTD | 217375 | AB (A-rated, therapeutically equivalent) | April 24, 2023 | 20MG, 40MG |
| ALKEM LABORATORIES LTD | 216400 | AB (A-rated, therapeutically equivalent) | May 15, 2023 | 40MG/5ML |
| SOMERSET THERAPEUTICS LLC | 217655 | AB (A-rated, therapeutically equivalent) | June 16, 2023 | 40MG/5ML |
| CARNEGIE PHARMACEUTICALS LLC | 217137 | AB (A-rated, therapeutically equivalent) | July 7, 2023 | 40MG/5ML |
| ANNORA PHARMA PRIVATE LTD | 217330 | AB (A-rated, therapeutically equivalent) | August 17, 2023 | 40MG/5ML |
| MICRO LABS LTD | 217842 | AB (A-rated, therapeutically equivalent) | September 14, 2023 | 40MG/5ML |
| AJANTA PHARMA LTD | 217529 | AB (A-rated, therapeutically equivalent) | September 18, 2023 | 40MG/5ML |
| CONTRACT PHARMACAL CORP | 217669 | AB (A-rated, therapeutically equivalent) | December 20, 2023 | 20MG, 40MG |
| RISING PHARMA HOLDINGS INC | 218181 | AB (A-rated, therapeutically equivalent) | December 22, 2023 | 20MG, 40MG |
| PHARMAZONE | 217605 | AB (A-rated, therapeutically equivalent) | January 16, 2024 | 40MG/5ML |
| MSN LABORATORIES PRIVATE LTD | 217400 | AB (A-rated, therapeutically equivalent) | August 6, 2024 | 20MG, 40MG |
| EPIC PHARMA LLC | 218344 | AB (A-rated, therapeutically equivalent) | October 16, 2024 | 40MG/5ML |
| REGCON HOLDINGS LLC | 218631 | AB (A-rated, therapeutically equivalent) | March 25, 2025 | 20MG, 40MG |
| LANNETT CO INC | 217982 | AB (A-rated, therapeutically equivalent) | June 2, 2025 | 40MG/5ML |
| AUROBINDO PHARMA LTD | 219091 | AB (A-rated, therapeutically equivalent) | July 9, 2025 | 40MG/5ML |
| MSN LABORATORIES PRIVATE LTD | 219863 | AB (A-rated, therapeutically equivalent) | July 24, 2025 | 40MG/5ML |
| CONTRACT PHARMACAL CORP | 219603 | AB (A-rated, therapeutically equivalent) | March 9, 2026 | 40MG/5ML |
| LUPIN LTD | 217432 | AP (A-rated, therapeutically equivalent) | May 12, 2026 | 10MG/ML |
Questions
Is there a generic for Pepcid?
Yes. The generic name for Pepcid is famotidine. 33 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP.
What is the generic name for Pepcid?
The active ingredient in Pepcid is famotidine, 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.