Nebivolol

Product NDC: 31722-588
Requested package NDC: 31722-588-34
11-digit product format: 317220588
Labeler code: 31722
Product ID: 31722-588_103af555-44dd-5dfb-e063-6294a90a259f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nebivolol
Dosage form: TABLET
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA203825
Marketing category: ANDA
Marketing start: 2021-09-17
Substance: NEBIVOLOL HYDROCHLORIDE
Active strength: 20 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 43.

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
A203825-001	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03
A203825-002	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03
A203825-003	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03
A203825-004	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203825-001	AB
A203825-002	AB
A203825-003	AB
A203825-004	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 · 152 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
2026-09-14 22:38:34	2026-08	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2020-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2020-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2020-11-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2020-11-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203825-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203825-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203825-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203825-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203825-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203825-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203825-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203825-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203825-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203825-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203825-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203825-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203825-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203825-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203825-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203825-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203825-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203825-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203825-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203825-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203825-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203825-004	AB	1	`5bbf6a4d5a75…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEBIVOLOL HYDROCHLORIDE	20 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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
387013	Internal RxNorm lookup
751612	Internal RxNorm lookup
751618	Internal RxNorm lookup
827073	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
202d5142-6180-4d48-9a9f-1bd6992fc49b	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	SPL version
31722-588-01	Nebivolol	100 in 1 BOTTLE	TABLET	100	2
31722-588-30	Nebivolol	30 in 1 BOTTLE	TABLET	30	2
31722-588-31	Nebivolol	10 in 1 BLISTER PACK	TABLET	10	2
31722-588-32	Nebivolol	10 in 1 CARTON	TABLET	10	2
31722-588-33	Nebivolol	7 in 1 BLISTER PACK	TABLET	7	2
31722-588-34	Nebivolol	18 in 1 CARTON	TABLET	18	2
31722-588-90	Nebivolol	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-588-30	EA - Each	31722-588	5c6b31dd-9227-4ff4-8294-20e5915efebb	1	2021-10-08
31722-588-90	EA - Each	31722-588	03c0cfc4-32dd-42a2-8cc1-fb6d343f0eca	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-588	NEBIVOLOL (NEBIVOLOL) TABLET [CAMBER PHARMACEUTICALS, INC.]	2	Current NDC, Legacy NDC, 7 package rows	20240201_202d5142-6180-4d48-9a9f-1bd6992fc49b.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nebivolol	NEBIVOLOL	Bryant Ranch Prepack	9f0bd0b4-ee17-46bb-b4e2-8ca0ea0e0489	2025-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203825 application number: ANDA203825
Nebivolol	NEBIVOLOL	Bryant Ranch Prepack	90d4ea48-7831-4cb0-8796-1ed79407c363	2024-10-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203825 application number: ANDA203825
Nebivolol	NEBIVOLOL	Proficient Rx LP	c6606db5-3937-4e90-9870-3cbfa4ec909e	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203825 application number: ANDA203825
Nebivolol	NEBIVOLOL	Camber Pharmaceuticals, Inc.	202d5142-6180-4d48-9a9f-1bd6992fc49b	2024-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203825 application number: ANDA203825 ndc (package): 31722-588-34 ndc (product): 31722-588 ndc11 (package): 31722058834

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	202d5142-6180-4d48-9a9f-1bd6992fc49b	2
751618	nebivolol 2.5 MG Oral Tablet	PSN	202d5142-6180-4d48-9a9f-1bd6992fc49b	2
827073	nebivolol 20 MG Oral Tablet	PSN	202d5142-6180-4d48-9a9f-1bd6992fc49b	2
387013	nebivolol 5 MG Oral Tablet	PSN	202d5142-6180-4d48-9a9f-1bd6992fc49b	2
751612	nebivolol 10 MG Oral Tablet	SCD	202d5142-6180-4d48-9a9f-1bd6992fc49b	2
751618	nebivolol 2.5 MG Oral Tablet	SCD	202d5142-6180-4d48-9a9f-1bd6992fc49b	2
827073	nebivolol 20 MG Oral Tablet	SCD	202d5142-6180-4d48-9a9f-1bd6992fc49b	2
387013	nebivolol 5 MG Oral Tablet	SCD	202d5142-6180-4d48-9a9f-1bd6992fc49b	2
751612	nebivolol (as nebivolol hydrochloride) 10 MG Oral Tablet	SY	202d5142-6180-4d48-9a9f-1bd6992fc49b	2
751618	nebivolol (as nebivolol hydrochloride) 2.5 MG Oral Tablet	SY	202d5142-6180-4d48-9a9f-1bd6992fc49b	2
827073	nebivolol (as nebivolol hydrochloride) 20 MG Oral Tablet	SY	202d5142-6180-4d48-9a9f-1bd6992fc49b	2
387013	nebivolol (as nebivolol hydrochloride) 5 MG Oral Tablet	SY	202d5142-6180-4d48-9a9f-1bd6992fc49b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-588-34	31722058834	18 BLISTER PACK in 1 CARTON (31722-588-34) / 7 TABLET in 1 BLISTER PACK (31722-588-33)	18 blister pack	2021-09-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nebivolol	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit III	2024-01-31	HUMAN PRESCRIPTION DRUG LABEL	2