Bystolic

Product NDC: 50090-1307
11-digit product format: 500901307
Labeler code: 50090
Product ID: 50090-1307_da3bdce8-aeb3-4113-b719-db34719d91da
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nebivolol hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: NDA021742
Marketing category: NDA
Marketing start: 2008-01-22
Marketing end: 0000-00-00
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: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50090-1307		D	Discontinued by firm	2026-08-11
excluded package	package	50090-1307	50090-1307-0	D	Discontinued by firm	2026-08-11
excluded package	package	50090-1307	50090-1307-1	D	Discontinued by firm	2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-1307-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-1307-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-1307-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-1307-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-1307-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-1307-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-1307-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-1307-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-1307-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-1307-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-1307-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-1307-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-1307-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-1307-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-1307-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-1307-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-1307-1	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-1307-0	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50090-1307-0	2023-02-07	These highlights do not include all the information needed to use Bystolic safely and effectively. See full prescribing information for Bystolic. Bystolic ® (nebivolol) t ablets , for oral use Initial U.S. Approval: 2007
50090-1307-1	2023-02-07	These highlights do not include all the information needed to use Bystolic safely and effectively. See full prescribing information for Bystolic. Bystolic ® (nebivolol) t ablets , for oral use Initial U.S. Approval: 2007
50090-1307-0	2023-01-30	These highlights do not include all the information needed to use Bystolic safely and effectively. See full prescribing information for Bystolic. Bystolic ® (nebivolol) t ablets , for oral use Initial U.S. Approval: 2007
50090-1307-1	2023-01-30	These highlights do not include all the information needed to use Bystolic safely and effectively. See full prescribing information for Bystolic. Bystolic ® (nebivolol) t ablets , for oral use Initial U.S. Approval: 2007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-1307-0	EA - Each	50090-1307	ca03bd58-0b84-4313-b7f9-0777792a33fc	1	2018-11-06
50090-1307-1	EA - Each	50090-1307	8804e665-9d3a-4ec7-a2d6-53a8663b431f	1	2021-09-07

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-1307-0	50090130700	30 TABLET in 1 BOTTLE (50090-1307-0)	30 tablet	2014-11-28	0000-00-00	No	No	Current
50090-1307-1	50090130701	90 TABLET in 1 BOTTLE (50090-1307-1)	90 tablet	2019-03-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Bystolic - A-S Medication Solutions	A-S Medication Solutions	2023-02-04	HUMAN PRESCRIPTION DRUG LABEL	27