Nebivolol

Product NDC: 72162-2414
11-digit product format: 721622414
Labeler code: 72162
Product ID: 72162-2414_089ab51c-85fc-44ad-80fc-7e56469ad9f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nebivolol
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA208717
Marketing category: ANDA
Marketing start: 2017-12-29
Substance: NEBIVOLOL HYDROCHLORIDE
Active strength: 10 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208717-001	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17
A208717-002	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17
A208717-003	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17
A208717-004	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A208717-001	AB
A208717-002	AB
A208717-003	AB
A208717-004	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208717-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2021-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208717-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2021-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208717-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2021-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208717-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2021-12-17	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208717-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208717-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208717-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208717-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208717-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208717-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208717-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208717-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208717-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208717-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208717-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208717-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208717-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208717-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208717-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208717-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208717-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208717-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208717-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nebivolol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEBIVOLOL HYDROCHLORIDE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
JGS34J7L9I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
751612	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
04a64dad-6922-4737-ab46-98c185782b38	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b9af42fa-00cc-b314-02ce-e06da0a12313	Product name	6	20250423
52311e76-a520-4bd2-9d5b-e0b6d6f44519	Product name	2	20231208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72162-2414-3	Nebivolol	30 in 1 BOTTLE	TABLET	30		100
72162-2414-9	Nebivolol	90 in 1 BOTTLE	TABLET	90		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-2414-3	EA - Each	72162-2414	86d2726d-32ea-411e-8f62-731303d443f9	1	2024-12-10
72162-2414-9	EA - Each	72162-2414	22f4640d-8e3c-43a5-9959-ddaed22eb494	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-2414	NEBIVOLOL TABLET [BRYANT RANCH PREPACK]	100	Current NDC, 2 package rows	20241102_04a64dad-6922-4737-ab46-98c185782b38.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nebivolol	NEBIVOLOL	Bryant Ranch Prepack	0ca84bf1-511d-480d-ba3d-0eef00ddad3e	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208717 application number: ANDA208717
Nebivolol	NEBIVOLOL	Bryant Ranch Prepack	04a64dad-6922-4737-ab46-98c185782b38	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208717 application number: ANDA208717 ndc (product): 72162-2414
Nebivolol	NEBIVOLOL	Bryant Ranch Prepack	abb0546f-08dd-4354-8b41-d17065b52c24	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208717 application number: ANDA208717
Nebivolol	NEBIVOLOL	Bryant Ranch Prepack	9a5e1bd8-f2b6-42e6-972d-09418528cd63	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208717 application number: ANDA208717
Nebivolol	NEBIVOLOL	Modavar Pharmaceuticals LLC	19d20396-ade8-400e-94f4-69913637d051	2023-11-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208717 application number: ANDA208717
Nebivolol	NEBIVOLOL	Cadila Pharmaceuticals Limited	451cdd6e-13b4-402f-8a44-cdf5f7433a49	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208717 application number: ANDA208717

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JGS34J7L9I	NEBIVOLOL HYDROCHLORIDE	152520-56-4	NEBIVOLOL HYDROCHLORIDE
030Y90569U	NEBIVOLOL	118457-14-0	Nebivolol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
751612	nebivolol 10 MG Oral Tablet	PSN	04a64dad-6922-4737-ab46-98c185782b38	100
751612	nebivolol 10 MG Oral Tablet	SCD	04a64dad-6922-4737-ab46-98c185782b38	100
751612	nebivolol (as nebivolol hydrochloride) 10 MG Oral Tablet	SY	04a64dad-6922-4737-ab46-98c185782b38	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72162-2414-3	72162241403	30 TABLET in 1 BOTTLE (72162-2414-3)	30 tablet	2024-10-31	No	No	Current
72162-2414-9	72162241409	90 TABLET in 1 BOTTLE (72162-2414-9)	90 tablet	2024-10-31	No	No	Current