NEBIVOLOL

Product NDC: 50090-7185
11-digit product format: 500907185
Labeler code: 50090
Product ID: 50090-7185_b6172758-7c8a-43a0-b3b2-43fa682c1459
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nebibolol
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA212682
Marketing category: ANDA
Marketing start: 2022-02-14
Substance: NEBIVOLOL
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
A212682-001	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2022-04-07
A212682-002	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2022-04-07
A212682-003	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2022-04-07
A212682-004	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2022-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212682-001	AB
A212682-002	AB
A212682-003	AB
A212682-004	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 3 · 116 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	A212682-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2022-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212682-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2022-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212682-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2022-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212682-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2022-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212682-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2022-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212682-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2022-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212682-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2022-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212682-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2022-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212682-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2022-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212682-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2022-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212682-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2022-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212682-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2022-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212682-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2022-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212682-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2022-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212682-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2022-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212682-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2022-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212682-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2022-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212682-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2022-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212682-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2022-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212682-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2022-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212682-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2022-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212682-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2022-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212682-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2022-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212682-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2022-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212682-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2022-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212682-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2022-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212682-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2022-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212682-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2022-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212682-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2022-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212682-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2022-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212682-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2022-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212682-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2022-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212682-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2022-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212682-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2022-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212682-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2022-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212682-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2022-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212682-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2022-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212682-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2022-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212682-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2022-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212682-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2022-04-07	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 116 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	A212682-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212682-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212682-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212682-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212682-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212682-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212682-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212682-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212682-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212682-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212682-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212682-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212682-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212682-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212682-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212682-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212682-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212682-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212682-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212682-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212682-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212682-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212682-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212682-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212682-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212682-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212682-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212682-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212682-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212682-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212682-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212682-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212682-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212682-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212682-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212682-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212682-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212682-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212682-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212682-004	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	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
030Y90569U	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
9b131f61-bed0-481b-a96e-3126958f9a9b	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
50090-7185-0	NEBIVOLOL	30 in 1 BOTTLE	TABLET	30		4
50090-7185-2	NEBIVOLOL	90 in 1 BOTTLE	TABLET	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7185-0	EA - Each	50090-7185	47333d23-5fce-4697-a033-39784c5f6ef7	1	2024-07-12
50090-7185-2	EA - Each	50090-7185	f85f2216-b8e4-4e97-b80f-61ba728e1d5a	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-7185	NEBIVOLOL (NEBIBOLOL) TABLET [A-S MEDICATION SOLUTIONS]	4	Current NDC, 2 package rows	20240626_9b131f61-bed0-481b-a96e-3126958f9a9b.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NEBIVOLOL	NEBIVOLOL	Major Pharmaceuticals	3e9e1048-b5ea-4d6a-9363-3ee0d059e088	2026-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212682 application number: ANDA212682
NEBIVOLOL	NEBIVOLOL	Solco Healthcare US, LLC	51d3f12f-94cc-4f58-94d3-61990e16adfc	2026-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212682 application number: ANDA212682
NEBIVOLOL	NEBIVOLOL	REMEDYREPACK INC.	a9bad35e-cd48-48f1-93ca-46490dbf70a8	2025-09-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212682 application number: ANDA212682
NEBIVOLOL	NEBIVOLOL	Bryant Ranch Prepack	126de78c-fb3d-4a53-9aaf-f2dfe1ac2a2f	2025-03-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212682 application number: ANDA212682
Nebivolol	NEBIVOLOL	Direct_Rx	25b5631c-44a3-05b4-e063-6394a90aeb7d	2024-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212682 application number: ANDA212682
NEBIVOLOL	NEBIVOLOL	A-S Medication Solutions	f20fda1a-437d-4812-b519-a26684c96c6d	2024-10-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212682 application number: ANDA212682
NEBIVOLOL	NEBIBOLOL	Bryant Ranch Prepack	78c0945a-b8dc-4397-95d5-9f209224ad5e	2024-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212682 application number: ANDA212682
NEBIVOLOL	NEBIVOLOL	Bryant Ranch Prepack	77fb6b5f-7bfe-4fc8-980c-fc688ac9837a	2024-07-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212682 application number: ANDA212682
NEBIVOLOL	NEBIBOLOL	A-S Medication Solutions	9b131f61-bed0-481b-a96e-3126958f9a9b	2024-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212682 application number: ANDA212682 ndc (product): 50090-7185

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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	9b131f61-bed0-481b-a96e-3126958f9a9b	4
751612	nebivolol 10 MG Oral Tablet	SCD	9b131f61-bed0-481b-a96e-3126958f9a9b	4
751612	nebivolol (as nebivolol hydrochloride) 10 MG Oral Tablet	SY	9b131f61-bed0-481b-a96e-3126958f9a9b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-7185-0	50090718500	30 TABLET in 1 BOTTLE (50090-7185-0)	30 tablet	2024-06-20	No	No	Current
50090-7185-2	50090718502	90 TABLET in 1 BOTTLE (50090-7185-2)	90 tablet	2024-06-20	No	No	Current