Nadolol

Product NDC: 50090-7995
Requested package NDC: 50090-7995-0
11-digit product format: 500907995
Labeler code: 50090
Product ID: 50090-7995_b5fb5f65-567f-4bdb-94f3-c3520f59200b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nadolol
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA208832
Marketing category: ANDA
Marketing start: 2017-06-02
Substance: NADOLOL
Active strength: 20 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A208832-001	NADOLOL	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02
A208832-002	NADOLOL	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02
A208832-003	NADOLOL	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A208832-001	AB
A208832-002	AB
A208832-003	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 · 129 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
2026-09-14 22:38:34	2026-08	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208832-002	NADOLOL	40MG	TABLET / ORAL	AB	2017-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208832-003	NADOLOL	80MG	TABLET / ORAL	AB	2017-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208832-001	NADOLOL	20MG	TABLET / ORAL	AB	2017-06-02	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208832-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208832-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208832-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208832-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208832-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208832-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208832-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208832-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208832-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208832-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208832-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208832-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208832-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208832-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208832-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208832-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208832-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208832-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208832-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208832-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208832-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208832-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208832-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208832-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208832-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208832-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208832-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208832-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208832-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208832-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208832-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208832-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208832-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208832-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208832-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208832-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208832-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208832-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208832-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208832-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Nadolol
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NADOLOL	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
FEN504330V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198006	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
4580b85b-437c-4c52-bf31-5976968ecd5c	Available on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nadolol	NADOLOL	A-S Medication Solutions	4580b85b-437c-4c52-bf31-5976968ecd5c	2026-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208832 application number: ANDA208832 ndc (package): 50090-7995-0 ndc (product): 50090-7995 ndc11 (package): 50090799500
Nadolol	NADOLOL	Amneal Pharmaceuticals NY LLC	e2e24b14-0169-4028-828a-894ad3c2ba55	2026-05-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208832 application number: ANDA208832

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
FEN504330V	NADOLOL	42200-33-9	NADOLOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-7995-0	50090799500	30 TABLET in 1 BOTTLE (50090-7995-0)	30 tablet	2026-06-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nadolol Tablets, USP (20 mg, 40 mg, and 80 mg) Rx only	A-S Medication Solutions	2026-06-19	HUMAN PRESCRIPTION DRUG LABEL	2