Nadolol

Product NDC: 67787-347
Requested package NDC: 67787-347-10
11-digit product format: 677870347
Labeler code: 67787
Product ID: 67787-347_1f70335d-208e-4e49-a891-2182e4383be5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Nadolol
Dosage form: TABLET
Route: ORAL
Labeler: InvaGen Pharmaceuticals Inc.
Application: ANDA203455
Marketing category: ANDA
Marketing start: 2015-12-18
Marketing end: 0000-00-00
Substance: NADOLOL
Active strength: 20 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	67787-347	67787-347-10	I	Inactivated by FDA		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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67787-347-10	2024-01-30	C162847	48780-1	1030e365-20d0-111a-e063-dadaa90a10e2	Rx Only
67787-347-30	2024-01-30	C162847	48780-1	1030e365-20d0-111a-e063-dadaa90a10e2	Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67787-347-10	Nadolol	1000 in 1 BOTTLE	TABLET	1000		2
67787-347-30	Nadolol	30 in 1 BOTTLE	TABLET	30		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67787-347	NADOLOL TABLET [INVAGEN PHARMACEUTICALS INC.]	2	Legacy NDC, 2 package rows	20170822_16d317c0-829a-4233-b1aa-b96348c4ca25.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
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	16d317c0-829a-4233-b1aa-b96348c4ca25	2
198007	nadolol 40 MG Oral Tablet	PSN	16d317c0-829a-4233-b1aa-b96348c4ca25	2
198008	nadolol 80 MG Oral Tablet	PSN	16d317c0-829a-4233-b1aa-b96348c4ca25	2
198006	nadolol 20 MG Oral Tablet	SCD	16d317c0-829a-4233-b1aa-b96348c4ca25	2
198007	nadolol 40 MG Oral Tablet	SCD	16d317c0-829a-4233-b1aa-b96348c4ca25	2
198008	nadolol 80 MG Oral Tablet	SCD	16d317c0-829a-4233-b1aa-b96348c4ca25	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67787-347-10	67787034710	1000 TABLET in 1 BOTTLE (67787-347-10)	1000 tablet	2015-12-18	0000-00-00	No	No	Current