FDA Orange Book
Generic for Augmentin '400'
Augmentin '400' 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 '400' 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 '400' products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 400MG/5ML;EQ 57MG BASE/5ML | Discontinued | None | 6 | AB |
| tablet, chewable, oral | 400MG;EQ 57MG BASE | Discontinued | None | 1 | None |
NDA 050725, 050726, 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 | 065066 | AB (A-rated, therapeutically equivalent) | June 5, 2002 | 400MG/5ML;EQ 57MG BASE/5ML |
| SANDOZ INC | 065098 | AB (A-rated, therapeutically equivalent) | December 16, 2002 | 400MG/5ML;EQ 57MG BASE/5ML |
| CHARTWELL RX SCIENCES LLC | 065089 | AB (A-rated, therapeutically equivalent) | May 25, 2004 | 400MG/5ML;EQ 57MG BASE/5ML |
| HIKMA PHARMACEUTICALS | 065191 | AB (A-rated, therapeutically equivalent) | January 25, 2005 | 400MG/5ML;EQ 57MG BASE/5ML |
| CHARTWELL RX SCIENCES LLC | 065205 | None (No TE code listed) | February 9, 2005 | 400MG;EQ 57MG BASE |
| AUROBINDO PHARMA LTD | 201090 | AB (A-rated, therapeutically equivalent) | December 20, 2011 | 400MG/5ML;EQ 57MG BASE/5ML |
| DEVA HOLDING AS | 210416 | AB (A-rated, therapeutically equivalent) | December 11, 2023 | 400MG/5ML;EQ 57MG BASE/5ML |
Augmentin '400' NDC codes
Questions
Is there a generic for Augmentin '400'?
Yes. The generic name for Augmentin '400' 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 '400'?
The active ingredient in Augmentin '400' 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.