FDA Orange Book
Generic for Principen '500'
Principen '500' 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 '500' is ampicillin/ampicillin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
Run it in Rivvi
Map Principen '500' and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Principen '500' products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 500MG BASE | Discontinued | None | 2 | AB |
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 |
|---|---|---|---|---|
| SANDOZ INC | 064082 | AB (A-rated, therapeutically equivalent) | August 29, 1995 | EQ 500MG BASE |
| AUROBINDO PHARMA LTD | 216554 | AB (A-rated, therapeutically equivalent) | October 31, 2023 | EQ 500MG BASE |
Questions
Is there a generic for Principen '500'?
Yes. The generic name for Principen '500' is ampicillin/ampicillin. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Principen '500'?
The active ingredient in Principen '500' 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.