Atenolol

Product NDC: 63629-2626
Requested package NDC: 63629-2626-2
11-digit product format: 636292626
Labeler code: 63629
Product ID: 63629-2626_616c33eb-2e98-43f0-8892-922fd4ebc982
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA077877
Marketing category: ANDA
Marketing start: 2007-12-04
Marketing end: 0000-00-00
Substance: ATENOLOL
Active strength: 100 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	63629-2626	63629-2626-2	D	Discontinued by firm		2026-08-03

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`

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	Approval date
A077877-001	ATENOLOL	ATENOLOL	25MG	TABLET / ORAL	AB	2006-12-27
A077877-002	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL	AB	2006-12-27
A077877-003	ATENOLOL	ATENOLOL	100MG	TABLET / ORAL	AB	2006-12-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077877-001	AB
A077877-002	AB
A077877-003	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A077877-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077877-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077877-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-12-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077877-001	ATENOLOL	25MG	TABLET / ORAL		2006-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077877-002	ATENOLOL	50MG	TABLET / ORAL		2006-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077877-003	ATENOLOL	100MG	TABLET / ORAL		2006-12-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077877-001	ATENOLOL	25MG	TABLET / ORAL		2006-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077877-002	ATENOLOL	50MG	TABLET / ORAL		2006-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077877-003	ATENOLOL	100MG	TABLET / ORAL		2006-12-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077877-001	ATENOLOL	25MG	TABLET / ORAL		2006-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077877-002	ATENOLOL	50MG	TABLET / ORAL		2006-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077877-003	ATENOLOL	100MG	TABLET / ORAL		2006-12-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077877-001	ATENOLOL	25MG	TABLET / ORAL		2006-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077877-002	ATENOLOL	50MG	TABLET / ORAL		2006-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077877-003	ATENOLOL	100MG	TABLET / ORAL		2006-12-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077877-001	ATENOLOL	25MG	TABLET / ORAL		2006-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077877-002	ATENOLOL	50MG	TABLET / ORAL		2006-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077877-003	ATENOLOL	100MG	TABLET / ORAL		2006-12-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077877-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077877-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077877-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-12-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077877-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077877-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077877-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-12-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077877-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077877-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077877-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-12-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077877-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077877-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077877-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-12-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077877-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077877-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077877-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-12-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077877-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077877-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077877-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-12-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077877-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077877-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077877-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-12-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077877-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-12-27	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 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	A077877-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077877-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077877-003	AB	1	`011fe1cb6892…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077877-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077877-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077877-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077877-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077877-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077877-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077877-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077877-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077877-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077877-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077877-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077877-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077877-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077877-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077877-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077877-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077877-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077877-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077877-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077877-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077877-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077877-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077877-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077877-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077877-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077877-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077877-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077877-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077877-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077877-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077877-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077877-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077877-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077877-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077877-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077877-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077877-001	AB	1	`bb7c543d1eb4…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-2626-1	2020-10-16	Atenolol Tablets, USP
63629-2626-2	2020-10-16	Atenolol Tablets, USP
63629-2626-3	2020-10-16	Atenolol Tablets, USP
63629-2626-4	2020-10-16	Atenolol Tablets, USP
63629-2626-5	2020-10-16	Atenolol Tablets, USP
63629-2626-1	2020-01-31	Atenolol Tablets, USP
63629-2626-2	2020-01-31	Atenolol Tablets, USP
63629-2626-3	2020-01-31	Atenolol Tablets, USP
63629-2626-4	2020-01-31	Atenolol Tablets, USP
63629-2626-5	2020-01-31	Atenolol Tablets, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-2626-1	EA - Each	63629-2626	bbd4d8ad-f4fe-4f82-b547-ac402eafeb8d	1	2012-07-24
63629-2626-2	EA - Each	63629-2626	c7f5478d-5642-4c18-97d3-dace4c1633f5	1	2012-07-24
63629-2626-3	EA - Each	63629-2626	571681ca-ebc0-4519-8fac-a862585e4438	1	2012-07-24
63629-2626-4	EA - Each	63629-2626	2162c485-1b4d-48bc-aa19-613a40834a92	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATENOLOL	ACTIVE INGREDIENT	50VV3VW0TI	ATENOLOL TABLET [BRYANT RANCH PREPACK]	2
ATENOLOL	ACTIVE MOIETY	50VV3VW0TI	ATENOLOL TABLET [BRYANT RANCH PREPACK]	2
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	ATENOLOL TABLET [BRYANT RANCH PREPACK]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATENOLOL TABLET [BRYANT RANCH PREPACK]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATENOLOL TABLET [BRYANT RANCH PREPACK]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ATENOLOL TABLET [BRYANT RANCH PREPACK]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ATENOLOL TABLET [BRYANT RANCH PREPACK]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ATENOLOL TABLET [BRYANT RANCH PREPACK]	2

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	Ipca Laboratories Limited	98d29958-b026-4888-a516-7bb85bb7d479	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077877 application number: ANDA077877

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
50VV3VW0TI	ATENOLOL	29122-68-7	ATENOLOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-2626-2	63629262602	30 TABLET in 1 BOTTLE (63629-2626-2)	30 tablet	2009-01-21	0000-00-00	No	No	Current