FDA Orange Book

Generic for Pamelor

Pamelor contains nortriptyline. 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 Pamelor is nortriptyline. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.

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Pamelor products in the Orange Book

Pamelor products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
capsule, oral	EQ 10MG BASE	Discontinued	None	3	AB
capsule, oral	EQ 25MG BASE	Discontinued	None	3	AB
capsule, oral	EQ 50MG BASE	Discontinued	None	3	AB
capsule, oral	EQ 75MG BASE	Discontinued	None	3	AB
solution, oral	EQ 10MG BASE/5ML	Discontinued	None	2	AA

NDA 018013, 018012, 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 nortriptyline

Approved generic versions of Pamelor
Company	ANDA	TE code	Approved	Strengths
DR REDDYS LABORATORIES SA	073556	AB (A-rated, therapeutically equivalent)	March 30, 1992	EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE
TEVA PHARMACEUTICALS USA INC	074132	AB (A-rated, therapeutically equivalent)	March 27, 1995	EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE
TARO PHARMACEUTICAL INDUSTRIES LTD	075520	AB (A-rated, therapeutically equivalent)	May 8, 2000	EQ 10MG BASE, EQ 25MG BASE, EQ 50MG BASE, EQ 75MG BASE
PHARMACEUTICAL ASSOCIATES INC	075606	AA (A-rated, therapeutically equivalent)	August 23, 2000	EQ 10MG BASE/5ML
RUBICON RESEARCH LTD	217731	AA (A-rated, therapeutically equivalent)	August 15, 2023	EQ 10MG BASE/5ML

Pamelor NDC codes

Questions

Is there a generic for Pamelor?

Yes. The generic name for Pamelor is nortriptyline. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AB.

What is the generic name for Pamelor?

The active ingredient in Pamelor is nortriptyline, 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.