Nebivolol

Product NDC: 71209-060
11-digit product format: 712090060
Labeler code: 71209
Product ID: 71209-060_0ab335f1-2089-496b-b65f-02c697f6ee89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nebivolol
Dosage form: TABLET
Route: ORAL
Labeler: Cadila Pharmaceuticals Limited
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 · 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
451cdd6e-13b4-402f-8a44-cdf5f7433a49	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
71209-060-01	Nebivolol	30 in 1 BOTTLE	TABLET	30	7
71209-060-04	Nebivolol	90 in 1 BOTTLE	TABLET	90	7
71209-060-05	Nebivolol	100 in 1 BOTTLE	TABLET	100	7
71209-060-11	Nebivolol	1000 in 1 BOTTLE	TABLET	1000	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71209-060	NEBIVOLOL TABLET [CADILA PHARMACEUTICALS LIMITED]	7	Current NDC, Legacy NDC, 4 package rows	20231110_451cdd6e-13b4-402f-8a44-cdf5f7433a49.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
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 ndc (product): 71209-060

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	451cdd6e-13b4-402f-8a44-cdf5f7433a49	7
751618	nebivolol 2.5 MG Oral Tablet	PSN	451cdd6e-13b4-402f-8a44-cdf5f7433a49	7
827073	nebivolol 20 MG Oral Tablet	PSN	451cdd6e-13b4-402f-8a44-cdf5f7433a49	7
387013	nebivolol 5 MG Oral Tablet	PSN	451cdd6e-13b4-402f-8a44-cdf5f7433a49	7
751612	nebivolol 10 MG Oral Tablet	SCD	451cdd6e-13b4-402f-8a44-cdf5f7433a49	7
751618	nebivolol 2.5 MG Oral Tablet	SCD	451cdd6e-13b4-402f-8a44-cdf5f7433a49	7
827073	nebivolol 20 MG Oral Tablet	SCD	451cdd6e-13b4-402f-8a44-cdf5f7433a49	7
387013	nebivolol 5 MG Oral Tablet	SCD	451cdd6e-13b4-402f-8a44-cdf5f7433a49	7
751612	nebivolol (as nebivolol hydrochloride) 10 MG Oral Tablet	SY	451cdd6e-13b4-402f-8a44-cdf5f7433a49	7
751618	nebivolol (as nebivolol hydrochloride) 2.5 MG Oral Tablet	SY	451cdd6e-13b4-402f-8a44-cdf5f7433a49	7
827073	nebivolol (as nebivolol hydrochloride) 20 MG Oral Tablet	SY	451cdd6e-13b4-402f-8a44-cdf5f7433a49	7
387013	nebivolol (as nebivolol hydrochloride) 5 MG Oral Tablet	SY	451cdd6e-13b4-402f-8a44-cdf5f7433a49	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71209-060-01	71209006001	30 TABLET in 1 BOTTLE (71209-060-01)	30 tablet	2018-10-16	0000-00-00	No	No	Current
71209-060-04	71209006004	90 TABLET in 1 BOTTLE (71209-060-04)	90 tablet	2018-10-16	0000-00-00	No	No	Current
71209-060-05	71209006005	100 TABLET in 1 BOTTLE (71209-060-05)	100 tablet	2018-10-16	0000-00-00	No	No	Current
71209-060-11	71209006011	1000 TABLET in 1 BOTTLE (71209-060-11)	1000 tablet	2018-10-16	0000-00-00	No	No	Current