FDA Orange Book
Generic for Augmentin '500'
Augmentin '500' contains amoxicillin and clavulanate. 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 Augmentin '500' is amoxicillin and clavulanate. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Augmentin '500' products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 500MG;EQ 125MG BASE | Discontinued | None | 5 | AB |
NDA 050564, held by US ANTIBIOTICS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic amoxicillin and clavulanate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 065064 | AB (A-rated, therapeutically equivalent) | March 15, 2002 | 500MG;EQ 125MG BASE |
| CHARTWELL RX SCIENCES LLC | 065101 | AB (A-rated, therapeutically equivalent) | October 30, 2002 | 500MG;EQ 125MG BASE |
| AUROBINDO PHARMA LTD | 091569 | AB (A-rated, therapeutically equivalent) | January 20, 2012 | 500MG;EQ 125MG BASE |
| MICRO LABS LTD INDIA | 205707 | AB (A-rated, therapeutically equivalent) | December 30, 2016 | 500MG;EQ 125MG BASE |
| REGCON HOLDINGS LLC | 209992 | AB (A-rated, therapeutically equivalent) | September 15, 2023 | 500MG;EQ 125MG BASE |
Questions
Is there a generic for Augmentin '500'?
Yes. The generic name for Augmentin '500' is amoxicillin and clavulanate. 5 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 Augmentin '500'?
The active ingredient in Augmentin '500' is amoxicillin and clavulanate, 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.