FDA Orange Book

Generic for Methadose

Methadose contains methadone. 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 Methadose is methadone. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.

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Methadose products in the Orange Book

Methadose products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
concentrate, oral	10MG/ML	Marketed (Rx)	AA	5	AA

NDA 017116, held by SPECGX LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic methadone

Approved generic versions of Methadose
Company	ANDA	TE code	Approved	Strengths
HIKMA PHARMACEUTICALS USA INC	089897	AA (A-rated, therapeutically equivalent)	September 6, 1988	10MG/ML
VISTAPHARM LLC	040088	AA (A-rated, therapeutically equivalent)	November 30, 1994	10MG/ML
HIKMA PHARMACEUTICALS USA INC	040180	AA (A-rated, therapeutically equivalent)	April 30, 1998	10MG/ML
SPECGX LLC	207368	AA (A-rated, therapeutically equivalent)	August 22, 2019	10MG/ML
LANNETT CO INC	212093	AA (A-rated, therapeutically equivalent)	November 2, 2020	10MG/ML

Methadose NDC codes

Questions

Is there a generic for Methadose?

Yes. The generic name for Methadose is methadone. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.

What is the generic name for Methadose?

The active ingredient in Methadose is methadone, 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.