FDA Orange Book

Generic for Rectiv

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

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Rectiv products in the Orange Book

Rectiv products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
ointment, intra-anal	0.4%	Discontinued	None	5	AB

NDA 021359, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic nitroglycerin

Approved generic versions of Rectiv
Company	ANDA	TE code	Approved	Strengths
COSETTE PHARMACEUTICALS NC LABORATORIES LLC	216103	AB (A-rated, therapeutically equivalent)	February 16, 2024	0.4%
TP ANDA HOLDINGS LLC	212222	AB (A-rated, therapeutically equivalent)	November 29, 2024	0.4%
ENCUBE ETHICALS PRIVATE LTD	216452	AB (A-rated, therapeutically equivalent)	December 16, 2024	0.4%
AMVIKA PHARMA LLC	218756	AB (A-rated, therapeutically equivalent)	December 18, 2025	0.4%
PADAGIS ISRAEL PHARMACEUTICALS LTD	214565	AB (A-rated, therapeutically equivalent)	July 6, 2026	0.4%

Rectiv NDC codes

58914-301

Questions

Is there a generic for Rectiv?

Yes. The generic name for Rectiv is nitroglycerin. 5 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 Rectiv?

The active ingredient in Rectiv is nitroglycerin, 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.