FDA Orange Book

Generic for Onfi

Onfi contains clobazam. 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 Onfi is clobazam. 14 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Onfi products in the Orange Book

Onfi products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
suspension, oral	2.5MG/ML	Marketed (Rx)	AB	7	AB
tablet, oral	10MG	Marketed (Rx)	AB	10	AB
tablet, oral	20MG	Marketed (Rx)	AB	10	AB
tablet, oral	5MG	Discontinued	None	1	None

NDA 203993, 202067, held by LUNDBECK PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic clobazam

Approved generic versions of Onfi
Company	ANDA	TE code	Approved	Strengths
AMNEAL PHARMACEUTICALS LLC	210039	AB (A-rated, therapeutically equivalent)	October 22, 2018	2.5MG/ML
BIONPHARMA INC	208819	AB (A-rated, therapeutically equivalent)	October 22, 2018	2.5MG/ML
AMNEAL PHARMACEUTICALS CO GMBH	209718	AB (A-rated, therapeutically equivalent)	October 22, 2018	10MG, 20MG
BIONPHARMA INC	208825	AB (A-rated, therapeutically equivalent)	October 22, 2018	10MG, 20MG
HETERO LABS LTD UNIT III	209795	AB (A-rated, therapeutically equivalent)	October 22, 2018	10MG, 20MG
PHARMAZONE	209808	AB (A-rated, therapeutically equivalent)	October 22, 2018	10MG, 20MG
UPSHER SMITH LABORATORIES LLC	209687	AB (A-rated, therapeutically equivalent)	October 22, 2018	10MG, 20MG
ZYDUS PHARMACEUTICALS USA INC	211449	AB (A-rated, therapeutically equivalent)	October 22, 2018	10MG, 20MG
LUPIN LTD	210545	AB (A-rated, therapeutically equivalent)	December 14, 2018	10MG, 20MG
MICRO LABS LTD	211711	AB (A-rated, therapeutically equivalent)	January 30, 2019	10MG, 20MG
TARO PHARMACEUTICAL INDUSTRIES LTD	210978	AB (A-rated, therapeutically equivalent)	April 15, 2019	2.5MG/ML
ALKEM LABORATORIES LTD	212714	AB (A-rated, therapeutically equivalent)	September 6, 2019	10MG, 20MG, 5MG
HETERO LABS LTD UNIT III	209796	AB (A-rated, therapeutically equivalent)	February 24, 2020	2.5MG/ML
CHARTWELL MOLECULAR HOLDINGS LLC	213110	AB (A-rated, therapeutically equivalent)	April 24, 2020	2.5MG/ML
ALKEM LABORATORIES LTD	213039	AB (A-rated, therapeutically equivalent)	May 6, 2021	2.5MG/ML
MSN LABORATORIES PRIVATE LTD	213404	AB (A-rated, therapeutically equivalent)	May 11, 2021	10MG, 20MG
AUROBINDO PHARMA LTD	214404	AB (A-rated, therapeutically equivalent)	March 24, 2022	2.5MG/ML

Onfi NDC codes

Questions

Is there a generic for Onfi?

Yes. The generic name for Onfi is clobazam. 14 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 Onfi?

The active ingredient in Onfi is clobazam, 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.