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NEBIVOLOL HYDROCHLORIDE

ANDA

NEBIVOLOL HYDROCHLORIDE | A216568 | REGCON HOLDINGS LLC

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: BYSTOLIC(TE code: AB)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-10-21 | 8 NDCs

Highest NADAC/Unit

$0.1717

per ea

Lowest NADAC/Unit

$0.1145

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
24689016201NEBIVOLOL 20 MG TABLET	$0.1717	EA	Generic	—	2026-10-21
24689016202NEBIVOLOL 20 MG TABLET	$0.1717	EA	Generic	—	2026-10-21
24689016101NEBIVOLOL 10 MG TABLET	$0.1469	EA	Generic	—	2026-10-21
24689016102NEBIVOLOL 10 MG TABLET	$0.1469	EA	Generic	—	2026-10-21
24689016001NEBIVOLOL 5 MG TABLET	$0.1153	EA	Generic	—	2026-10-21
24689016002NEBIVOLOL 5 MG TABLET	$0.1153	EA	Generic	—	2026-10-21
24689015901NEBIVOLOL 2.5 MG TABLET	$0.1145	EA	Generic	—	2026-10-21
24689015902NEBIVOLOL 2.5 MG TABLET	$0.1145	EA	Generic	—	2026-10-21

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 7 NDCs (7 FSS)

Lowest Price

$33.09

Highest Price

$90.49

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
24689-0159-01NEBIVOLOL 2.5MG TAB	$34.89	FSS	Apnar Pharma, LP	06/14/2026
24689-0160-01NEBIVOLOL 5MG TAB	$33.92	FSS	Apnar Pharma, LP	06/14/2026
24689-0160-02NEBIVOLOL 5MG TAB	$90.49	FSS	Apnar Pharma, LP	06/14/2026
24689-0161-01NEBIVOLOL 10MG TAB	$33.95	FSS	Apnar Pharma, LP	06/14/2026
24689-0161-02NEBIVOLOL 10MG TAB	$90.27	FSS	Apnar Pharma, LP	06/14/2026
24689-0162-01NEBIVOLOL 20MG TAB	$33.09	FSS	Apnar Pharma, LP	06/14/2026
24689-0162-02NEBIVOLOL 20MG TAB	$88.11	FSS	Apnar Pharma, LP	06/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain13 active DMFs1 inactive

12 active API suppliers hold Drug Master Files for this ingredient.

CADILA PHARMACEUTICALS LTDNEBIVOLOL HYDROCHLORIDE

DMF 211522007

FIS FABBRICA ITALIANA SINTETICI SPANEBIVOLOL HYDROCHLORIDE

DMF 227352009

TORRENT PHARMACEUTICALS LTDNEBIVOLOL HYDROCHLORIDE

DMF 229062009

MSN PHARMACHEM PRIVATE LTDNEBIVOLOL HYDROCHLORIDE [ROUTE CODE: 'NH']

DMF 249162011

HETERO DRUGS LTDNEBIVOLOL HYDROCHLORIDE

DMF 252962011

HONOUR LAB LTDNEBIVOLOL HYDROCHLORIDE

DMF 286272014

ZHEJIANG AUSUN PHARMACEUTICAL CO LTDNEBIVOLOL HYDROCHLORIDE

DMF 297302015

MACLEODS PHARMACEUTICALS LTDNEBIVOLOL HYDROCHLORIDE

DMF 299962016

CORDEN PHARMA CHENOVENEBIVOLOL HYDROCHLORIDE

DMF 300522015

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDNEBIVOLOL HYDROCHLORIDE

DMF 308482016

HETERO DRUGS LTDNEBIVOLOL HYDROCHLORIDE (PROCESS-II)

DMF 310812016

SMAART PHARMACEUTTICALSNEBIVOLOL HYDROCHLORIDE

DMF 353322021

ALKEM LABORATORIES LTDNEBIVOLOL HYDROCHLORIDE

DMF 393132024

DR REDDYS LABORATORIES LTDInactiveNEBIVOLOL HYDROCHLORIDE

DMF 248212011

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (4)

Sort:

#001 — EQ 2.5MG BASE

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 30, 2023

No patent or exclusivity listings for this strength.

#002 — EQ 5MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 30, 2023

#003 — EQ 10MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 30, 2023

#004 — EQ 20MG BASE

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Mar 30, 2023