NADOLOL

Product NDC: 62332-402
Requested package NDC: 62332-402-30
11-digit product format: 623320402
Labeler code: 62332
Product ID: 62332-402_95bac104-64eb-4a09-9c98-ed82ba912ab6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NADOLOL
Dosage form: TABLET
Route: ORAL
Labeler: Alembic Pharmaceuticals Inc.
Application: ANDA211763
Marketing category: ANDA
Marketing start: 2023-06-08
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
A211763-001	NADOLOL	NADOLOL	20MG	TABLET / ORAL	AB	2023-06-02
A211763-002	NADOLOL	NADOLOL	40MG	TABLET / ORAL	AB	2023-06-02
A211763-003	NADOLOL	NADOLOL	80MG	TABLET / ORAL	AB	2023-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211763-001	AB
A211763-002	AB
A211763-003	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 2 · 72 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	A211763-001	NADOLOL	20MG	TABLET / ORAL	AB	2023-06-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211763-002	NADOLOL	40MG	TABLET / ORAL	AB	2023-06-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211763-003	NADOLOL	80MG	TABLET / ORAL	AB	2023-06-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211763-001	NADOLOL	20MG	TABLET / ORAL	AB	2023-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211763-002	NADOLOL	40MG	TABLET / ORAL	AB	2023-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211763-003	NADOLOL	80MG	TABLET / ORAL	AB	2023-06-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211763-001	NADOLOL	20MG	TABLET / ORAL	AB	2023-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211763-002	NADOLOL	40MG	TABLET / ORAL	AB	2023-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211763-003	NADOLOL	80MG	TABLET / ORAL	AB	2023-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211763-001	NADOLOL	20MG	TABLET / ORAL	AB	2023-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211763-002	NADOLOL	40MG	TABLET / ORAL	AB	2023-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211763-003	NADOLOL	80MG	TABLET / ORAL	AB	2023-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211763-001	NADOLOL	20MG	TABLET / ORAL	AB	2023-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211763-002	NADOLOL	40MG	TABLET / ORAL	AB	2023-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211763-003	NADOLOL	80MG	TABLET / ORAL	AB	2023-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211763-001	NADOLOL	20MG	TABLET / ORAL	AB	2023-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211763-002	NADOLOL	40MG	TABLET / ORAL	AB	2023-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211763-003	NADOLOL	80MG	TABLET / ORAL	AB	2023-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211763-001	NADOLOL	20MG	TABLET / ORAL	AB	2023-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211763-002	NADOLOL	40MG	TABLET / ORAL	AB	2023-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211763-003	NADOLOL	80MG	TABLET / ORAL	AB	2023-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211763-001	NADOLOL	20MG	TABLET / ORAL	AB	2023-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211763-002	NADOLOL	40MG	TABLET / ORAL	AB	2023-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211763-003	NADOLOL	80MG	TABLET / ORAL	AB	2023-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211763-001	NADOLOL	20MG	TABLET / ORAL	AB	2023-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211763-002	NADOLOL	40MG	TABLET / ORAL	AB	2023-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211763-003	NADOLOL	80MG	TABLET / ORAL	AB	2023-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211763-001	NADOLOL	20MG	TABLET / ORAL	AB	2023-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211763-002	NADOLOL	40MG	TABLET / ORAL	AB	2023-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211763-003	NADOLOL	80MG	TABLET / ORAL	AB	2023-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211763-001	NADOLOL	20MG	TABLET / ORAL	AB	2023-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211763-002	NADOLOL	40MG	TABLET / ORAL	AB	2023-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211763-003	NADOLOL	80MG	TABLET / ORAL	AB	2023-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211763-001	NADOLOL	20MG	TABLET / ORAL	AB	2023-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211763-002	NADOLOL	40MG	TABLET / ORAL	AB	2023-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211763-003	NADOLOL	80MG	TABLET / ORAL	AB	2023-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211763-001	NADOLOL	20MG	TABLET / ORAL	AB	2023-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211763-002	NADOLOL	40MG	TABLET / ORAL	AB	2023-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211763-003	NADOLOL	80MG	TABLET / ORAL	AB	2023-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211763-001	NADOLOL	20MG	TABLET / ORAL	AB	2023-06-02	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 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	A211763-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211763-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211763-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211763-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211763-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211763-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211763-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211763-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211763-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211763-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211763-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211763-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211763-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211763-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211763-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211763-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211763-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211763-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211763-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211763-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211763-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211763-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211763-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211763-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211763-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211763-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211763-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211763-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211763-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211763-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211763-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211763-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211763-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211763-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211763-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211763-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211763-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211763-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211763-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211763-001	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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198006	Internal RxNorm lookup
198007	Internal RxNorm lookup
198008	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
6ab029aa-dfe0-4abb-8c7f-2692fe6a2368	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c3e14ce3-3dd7-c88b-aff9-2af221ac8a37	Product name	9	20240606
8fcb295c-5817-6981-e90d-9999d4e8f347	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
62332-402-30	NADOLOL	30 in 1 BOTTLE	TABLET	30	6
62332-402-31	NADOLOL	100 in 1 BOTTLE	TABLET	100	6
62332-402-91	NADOLOL	1000 in 1 BOTTLE	TABLET	1000	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62332-402	NADOLOL TABLET [ALEMBIC PHARMACEUTICALS INC.]	6	Current NDC, 3 package rows	20240322_6ab029aa-dfe0-4abb-8c7f-2692fe6a2368.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NADOLOL	NADOLOL	Bryant Ranch Prepack	64a788d0-b7f0-4f39-8adb-ab68870ecfa5	2026-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211763 application number: ANDA211763
NADOLOL	NADOLOL	Alembic Pharmaceuticals Inc.	6ab029aa-dfe0-4abb-8c7f-2692fe6a2368	2024-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211763 application number: ANDA211763 ndc (package): 62332-402-30 ndc (product): 62332-402 ndc11 (package): 62332040230
NADOLOL	NADOLOL	Alembic Pharmaceuticals Limited	0bd202e3-c673-4945-b828-1a5bc6a896ae	2023-06-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211763 application number: ANDA211763

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198006	nadolol 20 MG Oral Tablet	PSN	6ab029aa-dfe0-4abb-8c7f-2692fe6a2368	6
198007	nadolol 40 MG Oral Tablet	PSN	6ab029aa-dfe0-4abb-8c7f-2692fe6a2368	6
198008	nadolol 80 MG Oral Tablet	PSN	6ab029aa-dfe0-4abb-8c7f-2692fe6a2368	6
198006	nadolol 20 MG Oral Tablet	SCD	6ab029aa-dfe0-4abb-8c7f-2692fe6a2368	6
198007	nadolol 40 MG Oral Tablet	SCD	6ab029aa-dfe0-4abb-8c7f-2692fe6a2368	6
198008	nadolol 80 MG Oral Tablet	SCD	6ab029aa-dfe0-4abb-8c7f-2692fe6a2368	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62332-402-30	62332040230	30 TABLET in 1 BOTTLE (62332-402-30)	30 tablet	2023-06-08	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nadolol Tablets, USP Rx Only	Alembic Pharmaceuticals Inc. \| Alembic Pharmaceuticals Limited	2024-01-08	Human Prescription Drug Label	6