ATENOLOL

Product NDC: 61919-257
Requested package NDC: 61919-257-90
11-digit product format: 619190257
Labeler code: 61919
Product ID: 61919-257_9c5970fb-9b64-6e87-e053-2a95a90a6889
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATENOLOL
Dosage form: TABLET
Route: ORAL
Labeler: Direct Rx
Application: ANDA077877
Marketing category: ANDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: ATENOLOL
Active strength: 50 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	61919-257	61919-257-90	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 · 16 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	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
faf41ef3-b4b3-a29e-3b26-07c3009003bf	Product name	5	20220517
5eb1a708-d713-e905-0a08-b103c64796f4	Product name	3	20201019

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-257-30	2023-01-30	C162847	48780-1	f386c649-f497-0266-e053-dadaa90a7c1a	ATENOLOL
61919-257-90	2023-01-30	C162847	48780-1	f386c649-f497-0266-e053-dadaa90a7c1a	ATENOLOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-257-30	ATENOLOL	30 in 1 BOTTLE	TABLET	30		3
61919-257-90	ATENOLOL	90 in 1 BOTTLE	TABLET	90		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-257-30	EA - Each	61919-257	06b3386f-9796-418d-bdc2-67a76afa2d97	1	2015-10-02
61919-257-90	EA - Each	61919-257	828eb31f-e446-4914-b91c-65ff9930a63b	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATENOLOL	ACTIVE INGREDIENT	50VV3VW0TI	ATENOLOL TABLET [DIRECT RX]	1
ATENOLOL	ACTIVE MOIETY	50VV3VW0TI	ATENOLOL TABLET [DIRECT RX]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATENOLOL TABLET [DIRECT RX]	1
MAGNESIUM CARBONATE	INACTIVE INGREDIENT	0E53J927NA	ATENOLOL TABLET [DIRECT RX]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATENOLOL TABLET [DIRECT RX]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	ATENOLOL TABLET [DIRECT RX]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ATENOLOL TABLET [DIRECT RX]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ATENOLOL TABLET [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-257	ATENOLOL TABLET [DIRECT RX]	3	Legacy NDC, 2 package rows	20200118_32066d3f-dd94-4db6-943f-581a2f7104e7.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 · 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
197381	atenolol 50 MG Oral Tablet	PSN	32066d3f-dd94-4db6-943f-581a2f7104e7	3
197381	atenolol 50 MG Oral Tablet	SCD	32066d3f-dd94-4db6-943f-581a2f7104e7	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-257-90	61919025790	90 TABLET in 1 BOTTLE (61919-257-90)	90 tablet	2015-01-01	0000-00-00	No	No	Current