FDA Orange Book
Generic for Augmentin '125'
Augmentin '125' 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 '125' is amoxicillin and clavulanate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Augmentin '125' products the Orange Book lists.
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Augmentin '125' products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 125MG/5ML;EQ 31.25MG BASE/5ML | Marketed (Rx) | AB | 1 | AB |
| tablet, chewable, oral | 125MG;EQ 31.25MG BASE | Discontinued | None | 0 | None |
NDA 050575, 050597, 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 |
|---|---|---|---|---|
| AUROBINDO PHARMA LTD | 209371 | AB (A-rated, therapeutically equivalent) | April 19, 2019 | 125MG/5ML;EQ 31.25MG BASE/5ML |
Augmentin '125' NDC codes
Questions
Is there a generic for Augmentin '125'?
Yes. The generic name for Augmentin '125' is amoxicillin and clavulanate. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 1 of the 2 Augmentin '125' products the Orange Book lists.
What is the generic name for Augmentin '125'?
The active ingredient in Augmentin '125' 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.