FDA Orange Book

Generic for Bystolic

Bystolic contains nebivolol. 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 Bystolic is nebivolol. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.

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Bystolic products in the Orange Book

Bystolic products and approved generics
Form and route	Strength	Brand status	Brand TE	Active generics	Generic TE codes
tablet, oral	EQ 10MG BASE	Marketed (Rx)	AB	13	AB
tablet, oral	EQ 2.5MG BASE	Marketed (Rx)	AB	13	AB
tablet, oral	EQ 20MG BASE	Marketed (Rx)	AB	13	AB
tablet, oral	EQ 5MG BASE	Marketed (Rx)	AB	13	AB

NDA 021742, held by ALLERGAN SALES LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.

Approved generic nebivolol

Approved generic versions of Bystolic
Company	ANDA	TE code	Approved	Strengths
ANI PHARMACEUTICALS INC	203659	AB (A-rated, therapeutically equivalent)	April 16, 2015	EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE
INDCHEMIE HEALTH SPECIALTIES PVT LTD	203828	AB (A-rated, therapeutically equivalent)	July 29, 2015	EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE
GLENMARK PHARMACEUTICALS LTD	203821	AB (A-rated, therapeutically equivalent)	May 25, 2017	EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE
HETERO LABS LTD UNIT III	203825	AB (A-rated, therapeutically equivalent)	November 3, 2020	EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE
AUROBINDO PHARMA LTD	211053	AB (A-rated, therapeutically equivalent)	December 17, 2021	EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE
CADILA PHARMACEUTICALS LTD	208717	AB (A-rated, therapeutically equivalent)	December 17, 2021	EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE
REYOUNG CORPORATION	212917	AB (A-rated, therapeutically equivalent)	December 17, 2021	EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE
UNICHEM LABORATORIES LTD	213830	AB (A-rated, therapeutically equivalent)	March 15, 2022	EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE
PRINSTON PHARMACEUTICAL INC	212682	AB (A-rated, therapeutically equivalent)	April 7, 2022	EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE
MANKIND PHARMA LTD	216172	AB (A-rated, therapeutically equivalent)	November 14, 2022	EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE
REGCON HOLDINGS LLC	216568	AB (A-rated, therapeutically equivalent)	March 30, 2023	EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE
MSN LABORATORIES PRIVATE LTD	217397	AB (A-rated, therapeutically equivalent)	October 1, 2024	EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE
MACLEODS PHARMACEUTICALS LTD	212661	AB (A-rated, therapeutically equivalent)	January 28, 2025	EQ 10MG BASE, EQ 2.5MG BASE, EQ 20MG BASE, EQ 5MG BASE

Bystolic NDC codes

Questions

Is there a generic for Bystolic?

Yes. The generic name for Bystolic is nebivolol. 13 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 Bystolic?

The active ingredient in Bystolic is nebivolol, 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.