FDA Orange Book

Generic for Diprolene

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

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Diprolene products in the Orange Book

Diprolene products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
cream, augmented, topical	EQ 0.05% BASE	Discontinued	None	3	AB
gel, augmented, topical	EQ 0.05% BASE	Discontinued	None	2	AB
lotion, augmented, topical	EQ 0.05% BASE	Discontinued	None	3	AB
ointment, augmented, topical	EQ 0.05% BASE	Marketed (Rx)	AB	4	AB

NDA 019408, 019716, 018741, held by SCHERING CORP SUB SCHERING PLOUGH CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic betamethasone dipropionate

Approved generic versions of Diprolene
Company	ANDA	TE code	Approved	Strengths
ACTAVIS MID ATLANTIC LLC	074304	AB (A-rated, therapeutically equivalent)	August 31, 1995	EQ 0.05% BASE
FOUGERA PHARMACEUTICALS INC	075373	AB (A-rated, therapeutically equivalent)	June 22, 1999	EQ 0.05% BASE
FOUGERA PHARMACEUTICALS INC	075276	AB (A-rated, therapeutically equivalent)	May 13, 2003	EQ 0.05% BASE
SUN PHARMA CANADA INC	076508	AB (A-rated, therapeutically equivalent)	December 2, 2003	EQ 0.05% BASE
FOUGERA PHARMACEUTICALS INC	076215	AB (A-rated, therapeutically equivalent)	December 9, 2003	EQ 0.05% BASE
PADAGIS ISRAEL PHARMACEUTICALS LTD	076592	AB (A-rated, therapeutically equivalent)	December 9, 2003	EQ 0.05% BASE
SUN PHARMA CANADA INC	076543	AB (A-rated, therapeutically equivalent)	December 9, 2003	EQ 0.05% BASE
FOUGERA PHARMACEUTICALS INC	077111	AB (A-rated, therapeutically equivalent)	May 21, 2007	EQ 0.05% BASE
SUN PHARMA CANADA INC	077477	AB (A-rated, therapeutically equivalent)	May 21, 2007	EQ 0.05% BASE
ENCUBE ETHICALS PRIVATE LTD	206389	AB (A-rated, therapeutically equivalent)	February 13, 2018	EQ 0.05% BASE
LUPIN LTD	209106	AB (A-rated, therapeutically equivalent)	December 18, 2019	EQ 0.05% BASE
AUROBINDO PHARMA LTD	218289	AB (A-rated, therapeutically equivalent)	April 10, 2024	EQ 0.05% BASE

Diprolene NDC codes

Questions

Is there a generic for Diprolene?

Yes. The generic name for Diprolene is betamethasone dipropionate. 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 Diprolene?

The active ingredient in Diprolene is betamethasone dipropionate, 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.