FDA Orange Book

Generic for Marinol

Marinol contains dronabinol. 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 Marinol is dronabinol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Marinol products in the Orange Book

Marinol products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, oral	10MG	Marketed (Rx)	AB	1	AB
capsule, oral	2.5MG	Marketed (Rx)	AB	1	AB
capsule, oral	5MG	Marketed (Rx)	AB	1	AB

NDA 018651, held by ALKEM LABORATORIES LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic dronabinol

Approved generic versions of Marinol
Company	ANDA	TE code	Approved	Strengths
ASCENT PHARMACEUTICALS INC	207421	AB (A-rated, therapeutically equivalent)	February 7, 2020	10MG, 2.5MG, 5MG

Marinol NDC codes

Questions

Is there a generic for Marinol?

Yes. The generic name for Marinol is dronabinol. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

What is the generic name for Marinol?

The active ingredient in Marinol is dronabinol, 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.