FDA Orange Book

Generic for Augmentin Es-600

Augmentin Es-600 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 Es-600 is amoxicillin and clavulanate. 6 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Augmentin Es-600 products in the Orange Book

Augmentin Es-600 products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
for suspension, oral	600MG/5ML;EQ 42.9MG BASE/5ML	Marketed (Rx)	AB	6	AB

NDA 050755, 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

Approved generic versions of Augmentin Es-600
Company	ANDA	TE code	Approved	Strengths
CHARTWELL RX SCIENCES LLC	065162	AB (A-rated, therapeutically equivalent)	March 12, 2004	600MG/5ML;EQ 42.9MG BASE/5ML
SANDOZ INC	065358	AB (A-rated, therapeutically equivalent)	August 13, 2007	600MG/5ML;EQ 42.9MG BASE/5ML
HIKMA PHARMACEUTICALS	065373	AB (A-rated, therapeutically equivalent)	November 9, 2007	600MG/5ML;EQ 42.9MG BASE/5ML
AUROBINDO PHARMA LTD	201091	AB (A-rated, therapeutically equivalent)	December 20, 2011	600MG/5ML;EQ 42.9MG BASE/5ML
CIPLA LTD	065420	AB (A-rated, therapeutically equivalent)	December 2, 2013	600MG/5ML;EQ 42.9MG BASE/5ML
DEVA HOLDING AS	209351	AB (A-rated, therapeutically equivalent)	September 13, 2023	600MG/5ML;EQ 42.9MG BASE/5ML

Augmentin Es-600 NDC codes

Questions

Is there a generic for Augmentin Es-600?

Yes. The generic name for Augmentin Es-600 is amoxicillin and clavulanate. 6 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 Es-600?

The active ingredient in Augmentin Es-600 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.