FDA Orange Book
Generic for Pepcid Preservative Free
Pepcid Preservative Free 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 Preservative Free is famotidine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Pepcid Preservative Free products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 10MG/ML | Discontinued | None | 11 | AP |
NDA 019510, held by MERCK RESEARCH LABORATORIES DIV MERCK CO 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 |
| 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 |
| LUPIN LTD | 217432 | AP (A-rated, therapeutically equivalent) | May 12, 2026 | 10MG/ML |
Questions
Is there a generic for Pepcid Preservative Free?
Yes. The generic name for Pepcid Preservative Free is famotidine. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Pepcid Preservative Free?
The active ingredient in Pepcid Preservative Free 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.