Nadolol

Product NDC: 68001-318
11-digit product format: 680010318
Labeler code: 68001
Product ID: 68001-318_1980a55f-434f-5c45-e063-6394a90a014e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nadolol
Dosage form: TABLET
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA203455
Marketing category: ANDA
Marketing start: 2016-02-23
Substance: NADOLOL
Active strength: 40 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A203455-001	NADOLOL	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18
A203455-002	NADOLOL	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18
A203455-003	NADOLOL	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203455-001	AB
A203455-002	AB
A203455-003	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 · 123 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	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB	RS	2015-12-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB		2015-12-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB		2015-12-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203455-002	NADOLOL	40MG	TABLET / ORAL	AB		2015-12-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203455-003	NADOLOL	80MG	TABLET / ORAL	AB		2015-12-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203455-001	NADOLOL	20MG	TABLET / ORAL	AB		2015-12-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A203455-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203455-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203455-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203455-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203455-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203455-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203455-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203455-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203455-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203455-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203455-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203455-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203455-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203455-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203455-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203455-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203455-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203455-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203455-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203455-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203455-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203455-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203455-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203455-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203455-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203455-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203455-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203455-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203455-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203455-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203455-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203455-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203455-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203455-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203455-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203455-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203455-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203455-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203455-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203455-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Nadolol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NADOLOL	40 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
0a2acdc0-aab6-462e-a377-67a0f3d55ec6	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	Strength	SPL version
68001-318-00	Nadolol	100 in 1 BOTTLE	TABLET	100		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-318-00	EA - Each	68001-318	4ce4a388-8bfb-4be5-a39a-9a96685f95b3	1	2017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-318	NADOLOL TABLET [BLUEPOINT LABORATORIES]	5	Current NDC, Legacy NDC, 1 package rows	20240529_0a2acdc0-aab6-462e-a377-67a0f3d55ec6.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nadolol	NADOLOL	American Health Packaging	9e8e129d-cb17-45fc-b3e2-2600c0166463	2025-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203455 application number: ANDA203455
Nadolol	NADOLOL	BluePoint Laboratories	0a2acdc0-aab6-462e-a377-67a0f3d55ec6	2024-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203455 application number: ANDA203455 ndc (product): 68001-318
Nadolol	NADOLOL	Bryant Ranch Prepack	2fc1f850-9653-4082-929a-926b644810e7	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203455 application number: ANDA203455
Nadolol	NADOLOL	Bryant Ranch Prepack	9cf4ca73-2d38-44c2-a522-d44d536b5e55	2024-01-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203455 application number: ANDA203455
Nadolol	NADOLOL	Exelan Pharmaceuticals Inc.	5c6737f8-8fd8-4d8f-a66a-e99d3b64e1dd	2024-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203455 application number: ANDA203455
Nadolol	NADOLOL	Cipla USA Inc.	c899eedb-4113-45da-acc3-8e181250a7d8	2024-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203455 application number: ANDA203455

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	9e8e129d-cb17-45fc-b3e2-2600c0166463	7
198007	nadolol 40 MG Oral Tablet	PSN	9e8e129d-cb17-45fc-b3e2-2600c0166463	7
198006	nadolol 20 MG Oral Tablet	SCD	9e8e129d-cb17-45fc-b3e2-2600c0166463	7
198007	nadolol 40 MG Oral Tablet	SCD	9e8e129d-cb17-45fc-b3e2-2600c0166463	7
198006	nadolol 20 MG Oral Tablet	PSN	0a2acdc0-aab6-462e-a377-67a0f3d55ec6	5
198007	nadolol 40 MG Oral Tablet	PSN	0a2acdc0-aab6-462e-a377-67a0f3d55ec6	5
198008	nadolol 80 MG Oral Tablet	PSN	0a2acdc0-aab6-462e-a377-67a0f3d55ec6	5
198006	nadolol 20 MG Oral Tablet	SCD	0a2acdc0-aab6-462e-a377-67a0f3d55ec6	5
198007	nadolol 40 MG Oral Tablet	SCD	0a2acdc0-aab6-462e-a377-67a0f3d55ec6	5
198008	nadolol 80 MG Oral Tablet	SCD	0a2acdc0-aab6-462e-a377-67a0f3d55ec6	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-318-00	68001031800	100 TABLET in 1 BOTTLE (68001-318-00)	100 tablet	2017-01-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Nadolol Tablets, USP Rx Only 8430225/0124F	American Health Packaging	2025-07-23	HUMAN PRESCRIPTION DRUG LABEL	7
Nadolol Tablets, USP	BluePoint Laboratories \| Cipla USA Inc. \| InvaGen Pharmaceutical Inc	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	5