FDA Orange Book

Generic for Cleocin Hydrochloride

Cleocin Hydrochloride contains clindamycin. 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 Cleocin Hydrochloride is clindamycin. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Cleocin Hydrochloride products in the Orange Book

Cleocin Hydrochloride products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, oral	EQ 150MG BASE	Marketed (Rx)	AB	6	AB
capsule, oral	EQ 300MG BASE	Marketed (Rx)	AB	6	AB
capsule, oral	EQ 75MG BASE	Marketed (Rx)	AB	4	AB

NDA 050162, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic clindamycin

Approved generic versions of Cleocin Hydrochloride
Company	ANDA	TE code	Approved	Strengths
SUN PHARMACEUTICAL INDUSTRIES LTD	065061	AB (A-rated, therapeutically equivalent)	February 2, 2001	EQ 150MG BASE, EQ 300MG BASE
EPIC PHARMA LLC	065194	AB (A-rated, therapeutically equivalent)	March 22, 2004	EQ 150MG BASE, EQ 300MG BASE
ZYDUS PHARMACEUTICALS USA INC	065217	AB (A-rated, therapeutically equivalent)	January 31, 2005	EQ 150MG BASE, EQ 300MG BASE, EQ 75MG BASE
CHARTWELL MOLECULAR HOLDINGS LLC	065243	AB (A-rated, therapeutically equivalent)	August 12, 2005	EQ 75MG BASE
AUROBINDO PHARMA LTD	065442	AB (A-rated, therapeutically equivalent)	August 26, 2009	EQ 150MG BASE, EQ 300MG BASE
MICRO LABS LTD	207402	AB (A-rated, therapeutically equivalent)	November 5, 2018	EQ 150MG BASE, EQ 300MG BASE, EQ 75MG BASE
GLENMARK PHARMACEUTICALS LTD	216957	AB (A-rated, therapeutically equivalent)	March 10, 2023	EQ 150MG BASE, EQ 300MG BASE, EQ 75MG BASE

Cleocin Hydrochloride NDC codes

Questions

Is there a generic for Cleocin Hydrochloride?

Yes. The generic name for Cleocin Hydrochloride is clindamycin. 7 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 Cleocin Hydrochloride?

The active ingredient in Cleocin Hydrochloride is clindamycin, 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.