FDA Orange Book
Generic for Penbritin-s
Penbritin-s contains ampicillin. 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 Penbritin-s is ampicillin. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 5 of the 6 Penbritin-s products the Orange Book lists.
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Penbritin-s products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 125MG BASE/VIAL | Discontinued | None | 2 | AP |
| injectable, injection | EQ 1GM BASE/VIAL | Discontinued | None | 7 | AP |
| injectable, injection | EQ 250MG BASE/VIAL | Discontinued | None | 6 | AP |
| injectable, injection | EQ 2GM BASE/VIAL | Discontinued | None | 7 | AP |
| injectable, injection | EQ 4GM BASE/VIAL | Discontinued | None | 0 | None |
| injectable, injection | EQ 500MG BASE/VIAL | Discontinued | None | 6 | AP |
NDA 050072, held by WYETH AYERST LABORATORIES. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ampicillin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACS DOBFAR SPA | 062719 | AP (A-rated, therapeutically equivalent) | May 12, 1987 | EQ 1GM BASE/VIAL, EQ 250MG BASE/VIAL, EQ 500MG BASE/VIAL |
| HQ SPECIALTY PHARMA CORP | 062772 | AP (A-rated, therapeutically equivalent) | April 15, 1993 | EQ 1GM BASE/VIAL, EQ 250MG BASE/VIAL, EQ 2GM BASE/VIAL, EQ 500MG BASE/VIAL |
| ACS DOBFAR SPA | 062797 | AP (A-rated, therapeutically equivalent) | July 12, 1993 | EQ 2GM BASE/VIAL |
| ANTIBIOTICE SA | 090354 | AP (A-rated, therapeutically equivalent) | December 28, 2009 | EQ 1GM BASE/VIAL, EQ 250MG BASE/VIAL, EQ 2GM BASE/VIAL, EQ 500MG BASE/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 065499 | AP (A-rated, therapeutically equivalent) | August 17, 2010 | EQ 1GM BASE/VIAL, EQ 250MG BASE/VIAL, EQ 2GM BASE/VIAL, EQ 500MG BASE/VIAL |
| ONESOURCE SPECIALTY PTE LTD | 201025 | AP (A-rated, therapeutically equivalent) | April 9, 2014 | EQ 1GM BASE/VIAL, EQ 2GM BASE/VIAL |
| SAGENT PHARMACEUTICALS INC | 090583 | AP (A-rated, therapeutically equivalent) | November 27, 2015 | EQ 125MG BASE/VIAL, EQ 1GM BASE/VIAL, EQ 250MG BASE/VIAL, EQ 2GM BASE/VIAL, EQ 500MG BASE/VIAL |
| SANDOZ INC | 061395 | AP (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | EQ 125MG BASE/VIAL, EQ 1GM BASE/VIAL, EQ 250MG BASE/VIAL, EQ 2GM BASE/VIAL, EQ 500MG BASE/VIAL |
Questions
Is there a generic for Penbritin-s?
Yes. The generic name for Penbritin-s is ampicillin. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 5 of the 6 Penbritin-s products the Orange Book lists.
What is the generic name for Penbritin-s?
The active ingredient in Penbritin-s is ampicillin, 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.