FDA Orange Book

Generic for Miltown

Miltown contains meprobamate. 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 Miltown is meprobamate. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA.

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Miltown products in the Orange Book

Miltown products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	200MG	Discontinued	None	2	AA
tablet, oral	400MG	Discontinued	None	2	AA

NDA 009698, held by MEDPOINTE PHARMACEUTICALS MEDPOINTE HEALTHCARE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic meprobamate

Approved generic versions of Miltown
Company	ANDA	TE code	Approved	Strengths
INVAGEN PHARMACEUTICALS INC	040797	AA (A-rated, therapeutically equivalent)	February 27, 2008	200MG, 400MG
ALEMBIC PHARMACEUTICALS LTD	090122	AA (A-rated, therapeutically equivalent)	February 18, 2009	200MG, 400MG

Questions

Is there a generic for Miltown?

Yes. The generic name for Miltown is meprobamate. 2 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 Miltown?

The active ingredient in Miltown is meprobamate, 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.