Bystolic

Product NDC: 0456-1410
11-digit product format: 004561410
Labeler code: 0456
Product ID: 0456-1410_0096cdf0-43e6-4128-8990-aed7e1fab83f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nebivolol hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Allergan, Inc.
Application: NDA021742
Marketing category: NDA
Marketing start: 2008-01-22
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	RLD / RS	Approval date
N021742-002	BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17
N021742-003	BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17
N021742-004	BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17
N021742-005	BYSTOLIC	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021742-002	AB
N021742-003	AB
N021742-004	AB
N021742-005	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 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021742-002	BYSTOLIC	EQ 2.5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021742-003	BYSTOLIC	EQ 5MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021742-004	BYSTOLIC	EQ 10MG BASE	TABLET / ORAL	AB	RLD	2007-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021742-005	BYSTOLIC	EQ 20MG BASE	TABLET / ORAL	AB	RLD, RS	2008-10-08	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	N021742-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021742-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021742-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021742-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021742-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021742-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021742-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021742-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021742-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021742-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021742-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021742-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021742-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021742-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021742-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021742-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021742-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021742-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021742-005	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021742-002	6545040	2021-12-17	U-3	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021742-003	6545040	2021-12-17	U-3	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021742-004	6545040	2021-12-17	U-3	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021742-005	6545040	2021-12-17	U-3	Drug product	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021742-002	6545040	2021-12-17	U-3	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021742-003	6545040	2021-12-17	U-3	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021742-004	6545040	2021-12-17	U-3	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021742-005	6545040	2021-12-17	U-3	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021742-002	6545040	2021-12-17	U-3	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021742-003	6545040	2021-12-17	U-3	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021742-004	6545040	2021-12-17	U-3	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021742-005	6545040	2021-12-17	U-3	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021742-002	6545040	2021-12-17	U-3	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021742-003	6545040	2021-12-17	U-3	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021742-004	6545040	2021-12-17	U-3	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021742-005	6545040	2021-12-17	U-3	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021742-002	6545040	2021-12-17	U-3	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021742-003	6545040	2021-12-17	U-3	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021742-004	6545040	2021-12-17	U-3	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021742-005	6545040	2021-12-17	U-3	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021742-002	6545040	2021-12-17	U-3	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021742-003	6545040	2021-12-17	U-3	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021742-004	6545040	2021-12-17	U-3	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021742-005	6545040	2021-12-17	U-3	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021742-002	6545040	2021-12-17	U-3	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021742-003	6545040	2021-12-17	U-3	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021742-004	6545040	2021-12-17	U-3	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021742-005	6545040	2021-12-17	U-3	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021742-002	6545040	2021-12-17	U-3	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021742-003	6545040	2021-12-17	U-3	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021742-004	6545040	2021-12-17	U-3	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021742-005	6545040	2021-12-17	U-3	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021742-002	6545040	2021-12-17	U-3	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021742-003	6545040	2021-12-17	U-3	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021742-004	6545040	2021-12-17	U-3	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021742-005	6545040	2021-12-17	U-3	Drug product	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Bystolic
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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
387013	Internal RxNorm lookup
751612	Internal RxNorm lookup
751616	Internal RxNorm lookup
751618	Internal RxNorm lookup
751620	Internal RxNorm lookup
751623	Internal RxNorm lookup
827073	Internal RxNorm lookup
827075	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
8b8ad213-1dc8-454e-a524-075685c0e1a8	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
0456-1410-01	Bystolic	100 in 1 BOTTLE	TABLET	100	31
0456-1410-30	Bystolic	30 in 1 BOTTLE	TABLET	30	31
0456-1410-63	Bystolic	100 in 1 BOX, UNIT-DOSE	TABLET	100	31
0456-1410-90	Bystolic	90 in 1 BOTTLE	TABLET	90	31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0456-1410-01	EA - Each	0456-1410	3a7ef4c2-db59-467e-a854-ebb4e790b3d3	1	2012-07-24
0456-1410-30	EA - Each	0456-1410	72a8f8cd-3ceb-4121-a2ef-161a95599c17	1	2012-07-24
0456-1410-63	EA - Each	0456-1410	80a54fa8-9064-4fc0-84fb-d70664ed3068	1	2012-07-24
0456-1410-90	EA - Each	0456-1410	06f38395-3e7d-4208-8150-2c9beeb8a039	1	2014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
nebivolol hydrochloride	ACTIVE INGREDIENT	JGS34J7L9I	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]	12
nebivolol	ACTIVE MOIETY	030Y90569U	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]	12
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]	12
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]	12
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]	12
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]	12
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]	12
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]	12
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]	12
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]	12
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]	12
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]	12
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]	12
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [FOREST LABORATORIES, INC.]	12
NEBIVOLOL HYDROCHLORIDE	ACTIVE INGREDIENT	JGS34J7L9I	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	9
NEBIVOLOL	ACTIVE MOIETY	030Y90569U	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	9
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	9
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	9
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	9
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	9
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	9
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	9
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	9
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	9
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	9
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	9
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	9
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [CARDINAL HEALTH]	9
nebivolol hydrochloride	ACTIVE INGREDIENT	JGS34J7L9I	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
nebivolol	ACTIVE MOIETY	030Y90569U	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
cellulose, microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
croscarmellose sodium	INACTIVE INGREDIENT	M28OL1HH48	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2
starch, corn	INACTIVE INGREDIENT	O8232NY3SJ	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0456-1410	BYSTOLIC (NEBIVOLOL HYDROCHLORIDE) TABLET [ALLERGAN, INC.]	30	Current NDC, Legacy NDC, 4 package rows	20241105_8b8ad213-1dc8-454e-a524-075685c0e1a8.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bystolic	NEBIVOLOL HYDROCHLORIDE	Allergan, Inc.	8b8ad213-1dc8-454e-a524-075685c0e1a8	2024-08-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021742 application number: NDA021742 ndc (product): 0456-1410

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
JGS34J7L9I	NEBIVOLOL HYDROCHLORIDE	152520-56-4	NEBIVOLOL HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
751616	Bystolic 10 MG Oral Tablet	PSN	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751620	Bystolic 2.5 MG Oral Tablet	PSN	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
827075	Bystolic 20 MG Oral Tablet	PSN	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751623	Bystolic 5 MG Oral Tablet	PSN	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751612	nebivolol 10 MG Oral Tablet	PSN	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751618	nebivolol 2.5 MG Oral Tablet	PSN	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
827073	nebivolol 20 MG Oral Tablet	PSN	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
387013	nebivolol 5 MG Oral Tablet	PSN	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751616	nebivolol 10 MG Oral Tablet [Bystolic]	SBD	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751620	nebivolol 2.5 MG Oral Tablet [Bystolic]	SBD	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
827075	nebivolol 20 MG Oral Tablet [Bystolic]	SBD	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751623	nebivolol 5 MG Oral Tablet [Bystolic]	SBD	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751612	nebivolol 10 MG Oral Tablet	SCD	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751618	nebivolol 2.5 MG Oral Tablet	SCD	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
827073	nebivolol 20 MG Oral Tablet	SCD	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
387013	nebivolol 5 MG Oral Tablet	SCD	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751616	Bystolic (as nebivolol HCl) 10 MG Oral Tablet	SY	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751620	Bystolic (as nebivolol HCl) 2.5 MG Oral Tablet	SY	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
827075	Bystolic (as nebivolol HCl) 20 MG Oral Tablet	SY	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751623	Bystolic (as nebivolol HCl) 5 MG Oral Tablet	SY	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751616	Bystolic 10 MG Oral Tablet	SY	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751620	Bystolic 2.5 MG Oral Tablet	SY	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
827075	Bystolic 20 MG Oral Tablet	SY	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751623	Bystolic 5 MG Oral Tablet	SY	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751612	nebivolol (as nebivolol hydrochloride) 10 MG Oral Tablet	SY	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751618	nebivolol (as nebivolol hydrochloride) 2.5 MG Oral Tablet	SY	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
827073	nebivolol (as nebivolol hydrochloride) 20 MG Oral Tablet	SY	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
387013	nebivolol (as nebivolol hydrochloride) 5 MG Oral Tablet	SY	8b8ad213-1dc8-454e-a524-075685c0e1a8	31
751616	Bystolic 10 MG Oral Tablet	PSN	07ed02ff-523f-437e-bddc-5c41a4bb0062	2
751616	Bystolic 10 MG Oral Tablet	PSN	673f5ad2-c09b-4a89-9407-efdadd007917	2
751623	Bystolic 5 MG Oral Tablet	PSN	673f5ad2-c09b-4a89-9407-efdadd007917	2
751612	nebivolol 10 MG Oral Tablet	PSN	673f5ad2-c09b-4a89-9407-efdadd007917	2
751612	nebivolol 10 MG Oral Tablet	PSN	07ed02ff-523f-437e-bddc-5c41a4bb0062	2
387013	nebivolol 5 MG Oral Tablet	PSN	673f5ad2-c09b-4a89-9407-efdadd007917	2
751616	nebivolol 10 MG Oral Tablet [Bystolic]	SBD	673f5ad2-c09b-4a89-9407-efdadd007917	2
751616	nebivolol 10 MG Oral Tablet [Bystolic]	SBD	07ed02ff-523f-437e-bddc-5c41a4bb0062	2
751623	nebivolol 5 MG Oral Tablet [Bystolic]	SBD	673f5ad2-c09b-4a89-9407-efdadd007917	2
751612	nebivolol 10 MG Oral Tablet	SCD	673f5ad2-c09b-4a89-9407-efdadd007917	2
751612	nebivolol 10 MG Oral Tablet	SCD	07ed02ff-523f-437e-bddc-5c41a4bb0062	2
387013	nebivolol 5 MG Oral Tablet	SCD	673f5ad2-c09b-4a89-9407-efdadd007917	2
751616	Bystolic (as nebivolol HCl) 10 MG Oral Tablet	SY	673f5ad2-c09b-4a89-9407-efdadd007917	2
751616	Bystolic (as nebivolol HCl) 10 MG Oral Tablet	SY	07ed02ff-523f-437e-bddc-5c41a4bb0062	2
751623	Bystolic (as nebivolol HCl) 5 MG Oral Tablet	SY	673f5ad2-c09b-4a89-9407-efdadd007917	2
751616	Bystolic 10 MG Oral Tablet	SY	07ed02ff-523f-437e-bddc-5c41a4bb0062	2
751616	Bystolic 10 MG Oral Tablet	SY	673f5ad2-c09b-4a89-9407-efdadd007917	2
751623	Bystolic 5 MG Oral Tablet	SY	673f5ad2-c09b-4a89-9407-efdadd007917	2
751612	nebivolol (as nebivolol hydrochloride) 10 MG Oral Tablet	SY	07ed02ff-523f-437e-bddc-5c41a4bb0062	2
751612	nebivolol (as nebivolol hydrochloride) 10 MG Oral Tablet	SY	673f5ad2-c09b-4a89-9407-efdadd007917	2
387013	nebivolol (as nebivolol hydrochloride) 5 MG Oral Tablet	SY	673f5ad2-c09b-4a89-9407-efdadd007917	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0456-1410-01	00456141001	100 TABLET in 1 BOTTLE (0456-1410-01)	100 tablet	2008-01-22	0000-00-00	No	No	Current
0456-1410-30	00456141030	30 TABLET in 1 BOTTLE (0456-1410-30)	30 tablet	2008-01-22	0000-00-00	No	No	Current
0456-1410-63	00456141063	100 TABLET in 1 BOX, UNIT-DOSE (0456-1410-63)	100 tablet	2008-01-22	0000-00-00	No	No	Current
0456-1410-90	00456141090	90 TABLET in 1 BOTTLE (0456-1410-90)	90 tablet	2008-01-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bystolic - Allergan, Inc.	Allergan, Inc.	2024-08-01	HUMAN PRESCRIPTION DRUG LABEL	31
Bystolic - A-S Medication Solutions	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	27
Bystolic	Cardinal Health	2021-09-15	HUMAN PRESCRIPTION DRUG LABEL	19
Bystolic	Carilion Materials Management	2014-01-01	HUMAN PRESCRIPTION DRUG LABEL	2
Bystolic	Physicians Total Care, Inc.	2012-01-03	HUMAN PRESCRIPTION DRUG LABEL	2