nebivolol

Product NDC: 13668-356
11-digit product format: 136680356
Labeler code: 13668
Product ID: 13668-356_dd21623c-b76b-415e-9be7-d423f6719096
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nebivolol
Dosage form: TABLET
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA203966
Marketing category: ANDA
Marketing start: 2018-03-02
Marketing end: 0000-00-00
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: 2023-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	13668-356		D	Discontinued by firm	2026-10-15
excluded package	package	13668-356	13668-356-01	D	Discontinued by firm	2026-10-15
excluded package	package	13668-356	13668-356-05	D	Discontinued by firm	2026-10-15
excluded package	package	13668-356	13668-356-30	D	Discontinued by firm	2026-10-15
excluded package	package	13668-356	13668-356-90	D	Discontinued by firm	2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A203966-001	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	2018-03-02
A203966-002	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	2018-03-02
A203966-003	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	2018-03-02
A203966-004	NEBIVOLOL HYDROCHLORIDE	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	2018-03-02

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 · 176 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
2026-10-15 13:18:30	2026-09	A203966-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL		2018-03-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203966-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL		2018-03-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203966-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2018-03-02	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A203966-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL		2018-03-02	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A203966-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL		2018-03-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203966-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL		2018-03-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203966-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2018-03-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203966-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL		2018-03-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203966-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL		2018-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203966-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL		2018-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203966-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL		2018-03-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203966-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL		2018-03-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203966-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203966-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203966-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203966-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203966-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203966-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203966-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203966-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203966-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203966-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203966-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203966-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203966-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203966-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203966-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203966-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203966-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203966-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203966-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203966-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203966-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203966-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203966-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203966-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203966-001	NEBIVOLOL HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL	AB	2018-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203966-002	NEBIVOLOL HYDROCHLORIDE	EQ 5MG BASE	TABLET / ORAL	AB	2018-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203966-003	NEBIVOLOL HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2018-03-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203966-004	NEBIVOLOL HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2018-03-02	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 128 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203966-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203966-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203966-003	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203966-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203966-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203966-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203966-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203966-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203966-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203966-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203966-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203966-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203966-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203966-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203966-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203966-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203966-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203966-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203966-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203966-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203966-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203966-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203966-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203966-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203966-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203966-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203966-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203966-004	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203966-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203966-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203966-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203966-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203966-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203966-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203966-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203966-004	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203966-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203966-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203966-003	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203966-004	AB	1	`6a51e52b5d6a…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-356-30	EA - Each	13668-356	1cc5f277-7bd9-4d3e-bf0c-4d0506323788	1	2021-10-08
13668-356-90	EA - Each	13668-356	2cc9b106-51d1-47e5-b6de-b07552cc1d5e	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-356	NEBIVOLOL TABLET [TORRENT PHARMACEUTICALS LIMITED]	18	Legacy NDC	20241213_3e3dc363-731f-4115-b685-a17620dd2034.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-356-01	13668035601	100 TABLET in 1 BOTTLE (13668-356-01)	100 tablet	2021-08-19	0000-00-00	No	No	Current
13668-356-05	13668035605	500 TABLET in 1 BOTTLE (13668-356-05)	500 tablet	2018-03-02	0000-00-00	No	No	Current
13668-356-30	13668035630	30 TABLET in 1 BOTTLE (13668-356-30)	30 tablet	2018-03-02	0000-00-00	No	No	Current
13668-356-74	13668035674	100 TABLET in 1 CARTON (13668-356-74)	100 tablet	2021-08-19	0000-00-00	No	No	Current
13668-356-90	13668035690	90 TABLET in 1 BOTTLE (13668-356-90)	90 tablet	2021-06-17	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
nebivolol	Major Pharmaceuticals	2025-03-17	HUMAN PRESCRIPTION DRUG LABEL	7
nebivolol	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2024-12-11	HUMAN PRESCRIPTION DRUG LABEL	18