FDA Orange Book
Generic for Polycillin
Polycillin contains ampicillin/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 is ampicillin/ampicillin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 7 Polycillin products the Orange Book lists.
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Polycillin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 250MG BASE | Discontinued | None | 1 | None |
| capsule, oral | EQ 500MG BASE | Discontinued | None | 2 | AB |
| for suspension, oral | EQ 100MG BASE/ML | Discontinued | None | 0 | None |
| for suspension, oral | EQ 125MG BASE/5ML | Discontinued | None | 0 | None |
| for suspension, oral | EQ 250MG BASE/5ML | Discontinued | None | 0 | None |
| for suspension, oral | EQ 500MG BASE/5ML | Discontinued | None | 0 | None |
| tablet, chewable, oral | EQ 125MG BASE | Discontinued | None | 0 | None |
NDA 050310, 050308, 050093, 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/ampicillin
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 064082 | AB (A-rated, therapeutically equivalent) | August 29, 1995 | EQ 500MG BASE |
| AUROBINDO PHARMA LTD | 216554 | None (No TE code listed) | October 31, 2023 | EQ 250MG BASE, EQ 500MG BASE |
Questions
Is there a generic for Polycillin?
Yes. The generic name for Polycillin is ampicillin/ampicillin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 2 of the 7 Polycillin products the Orange Book lists.
What is the generic name for Polycillin?
The active ingredient in Polycillin is ampicillin/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.