ATENOLOL

Product NDC: 61919-935
Requested package NDC: 61919-935-90
11-digit product format: 619190935
Labeler code: 61919
Product ID: 61919-935_9c5970fb-9b7d-6e87-e053-2a95a90a6889
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ATENOLOL
Dosage form: TABLET
Route: ORAL
Labeler: Direct_Rx
Application: ANDA076900
Marketing category: ANDA
Marketing start: 2019-07-29
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	61919-935	61919-935-90	I	Inactivated by FDA		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 · 18 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…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
A076900-001	ATENOLOL	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28
A076900-002	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28
A076900-003	ATENOLOL	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076900-001	AB
A076900-002	AB
A076900-003	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	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`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	A076900-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076900-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076900-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076900-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076900-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076900-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076900-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076900-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076900-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076900-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076900-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076900-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076900-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076900-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076900-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076900-001	AB	1	`8072bd15b7f6…`

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
61919-935-90	2022-01-28	C162847	48780-1	d6a99b39-a00b-a426-e053-dadaa90af4c2	ATENOLOL
61919-935-30	2020-01-31	C162847	48780-1	9d75b9cf-dc8e-f424-e053-dadaa90a57ce	ATENOLOL
61919-935-60	2020-01-31	C162847	48780-1	9d75b9cf-dc8e-f424-e053-dadaa90a57ce	ATENOLOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61919-935-30	ATENOLOL	30 in 1 BOTTLE	TABLET	30	2
61919-935-60	ATENOLOL	60 in 1 BOTTLE	TABLET	60	2
61919-935-90	ATENOLOL	90 in 1 BOTTLE	TABLET	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-935-30	EA - Each	61919-935	d17e7109-30d9-4934-b7c6-4bc427fe1e84	1	2017-03-06
61919-935-60	EA - Each	61919-935	b76b7d61-8148-4002-8c22-266150882713	1	2017-09-11
61919-935-90	EA - Each	61919-935	402cd065-a6f5-4c68-b986-08e77bfecab3	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-935	ATENOLOL TABLET [DIRECT RX]	2	Legacy NDC, 2 package rows	20170719_494b88fa-a2b7-4835-e054-00144ff8d46c.zip
61919-935	ATENOLOL TABLET [DIRECT_RX]	2	Legacy NDC, 1 package rows	20200118_8ed726e8-8174-55f8-e053-2a95a90a8716.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	A-S Medication Solutions	b6fe1a12-a6d5-4c4c-9d77-6f717b43f8fe	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	A-S Medication Solutions	d21f2b4d-6584-48e5-8045-e5927ba03329	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	PD-Rx Pharmaceuticals, Inc.	8acdb229-928b-4c22-88f1-f4dd97cde274	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	PD-Rx Pharmaceuticals, Inc.	bdbf6779-8e9b-4ce1-a361-ede4914dd2f3	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	American Health Packaging	d19e9fcf-dfa1-43d7-94dc-e3f03fb90f5c	2024-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	Zydus Lifesciences Limited	2492d5f6-00b0-42c9-a793-2be83ea81ad1	2024-11-25		Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	NuCare Pharmaceuticals, Inc.	3d70576a-6fa7-481d-e054-00144ff88e88	2024-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	Bryant Ranch Prepack	67d9ca94-2af6-4ebb-a5c3-8d360f741277	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	Zydus Pharmaceuticals USA Inc.	db801706-1362-44c7-92ab-f584f96c7e1c	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900

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	494b88fa-a2b7-4835-e054-00144ff8d46c	2
197381	atenolol 50 MG Oral Tablet	PSN	8ed726e8-8174-55f8-e053-2a95a90a8716	2
197381	atenolol 50 MG Oral Tablet	SCD	494b88fa-a2b7-4835-e054-00144ff8d46c	2
197381	atenolol 50 MG Oral Tablet	SCD	8ed726e8-8174-55f8-e053-2a95a90a8716	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-935-90	61919093590	90 TABLET in 1 BOTTLE (61919-935-90)	90 tablet	2019-07-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ATENOLOL	Direct_Rx	2020-01-17	HUMAN PRESCRIPTION DRUG LABEL	2
ATENOLOL	DIRECT RX	2017-07-19	HUMAN PRESCRIPTION DRUG LABEL	2