FDA Orange Book
Generic for Principen '250'
Principen '250' 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 Principen '250' is ampicillin/ampicillin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
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Principen '250' 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 |
NDA 050056, held by APOTHECON SUB BRISTOL MYERS SQUIBB 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 |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 216554 | None (No TE code listed) | October 31, 2023 | EQ 250MG BASE |
Questions
Is there a generic for Principen '250'?
Yes. The generic name for Principen '250' is ampicillin/ampicillin. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book.
What is the generic name for Principen '250'?
The active ingredient in Principen '250' 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.