FDA Orange Book
Generic for Polycillin-n
Polycillin-n 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 Polycillin-n is ampicillin. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Polycillin-n 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 500MG BASE/VIAL | Discontinued | None | 6 | AP |
NDA 050309, held by BRISTOL LABORATORIES INC DIV BRISTOL MYERS CO. 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 Polycillin-n?
Yes. The generic name for Polycillin-n is ampicillin. 7 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 Polycillin-n?
The active ingredient in Polycillin-n 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.