Atenolol

Product NDC: 68071-4538
11-digit product format: 680714538
Labeler code: 68071
Product ID: 68071-4538_1a911dea-5bfe-c197-e063-6394a90acda0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA077443
Marketing category: ANDA
Marketing start: 2010-06-10
Substance: ATENOLOL
Active strength: 25 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	Approval date
A077443-001	ATENOLOL	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13
A077443-002	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13
A077443-003	ATENOLOL	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077443-001	AB
A077443-002	AB
A077443-003	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	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077443-002	ATENOLOL	50MG	TABLET / ORAL	AB	2006-09-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077443-003	ATENOLOL	100MG	TABLET / ORAL	AB	2006-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077443-001	ATENOLOL	25MG	TABLET / ORAL	AB	2006-09-13	`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	A077443-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077443-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077443-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077443-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077443-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077443-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077443-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077443-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077443-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077443-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077443-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077443-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077443-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077443-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077443-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077443-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077443-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077443-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077443-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077443-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077443-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077443-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077443-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077443-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077443-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077443-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077443-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077443-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077443-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077443-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077443-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077443-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077443-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077443-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077443-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077443-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077443-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077443-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077443-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077443-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATENOLOL	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
50VV3VW0TI	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197380	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
741f328d-21a1-3b19-e053-2a91aa0aa327	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68071-4538-3	Atenolol	30 in 1 BOTTLE	TABLET	30	6
68071-4538-5	Atenolol	45 in 1 BOTTLE	TABLET	45	6
68071-4538-6	Atenolol	60 in 1 BOTTLE	TABLET	60	6
68071-4538-8	Atenolol	180 in 1 BOTTLE	TABLET	180	6
68071-4538-9	Atenolol	90 in 1 BOTTLE	TABLET	90	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4538	ATENOLOL TABLET [NUCARE PHARMACEUTICALS,INC.]	6	Current NDC, Legacy NDC, 5 package rows	20240612_741f328d-21a1-3b19-e053-2a91aa0aa327.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	St. Mary's Medical Park Pharmacy	7f8304a4-93de-774f-e053-2a91aa0aa5b5	2026-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	St Mary's Medical Park Pharmacy	78d394b8-8ffb-a846-e053-2991aa0aa58c	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	St. Mary's Medical Park Pharmacy	8501f6c1-8157-4189-e053-2a91aa0ac4ef	2026-06-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Preferred Pharmaceuticals, Inc.	26d3df38-20c6-40e0-a456-da4f10fff632	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Preferred Pharmaceuticals, Inc.	a8d48a47-ccab-4a35-a092-6e562683ade3	2026-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	82100fc8-5a5a-4d80-8101-72024ee0abef	2026-03-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
atenolol	ATENOLOL	direct rx	b3c757de-1cbf-61f5-e053-2995a90accfc	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	A-S Medication Solutions	43acd912-f0f4-47eb-b81f-cbbfed77c557	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	A-S Medication Solutions	e4ece8f4-3714-42ba-b36d-d00586dfd33a	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Northwind Health Company, LLC	db5bd8e2-1314-0f7f-e053-2995a90ae86e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	QPharma, Inc.	bd43e0b1-c05e-01ae-e053-2a95a90af1cd	2025-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Rising Pharma Holdings, Inc.	96dd038f-b363-4e24-9c67-82b7c85c3bc4	2025-05-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	8115a2bc-69aa-60b4-e053-2a91aa0aeae7	2025-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Direct_Rx	ee143f2f-be60-bc67-e053-2a95a90ae6e6	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
ATENOLOL	ATENOLOL	direct rx	b3d9f826-7ed7-1e3b-e053-2995a90ae731	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	9db36b04-f353-55d6-e053-2a95a90ae08f	2025-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Bryant Ranch Prepack	722d6532-20d0-4936-ae9c-b7bb593b960a	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Bryant Ranch Prepack	c7a8830a-5eda-4f0e-bf03-61ee8ed6558d	2024-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	Bryant Ranch Prepack	1d6ea66b-30ef-4829-b757-5ea9d412a666	2024-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	73671d55-3e10-cb1d-e053-2991aa0ac038	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077443 application number: ANDA077443

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
197380	atenolol 25 MG Oral Tablet	PSN	741f328d-21a1-3b19-e053-2a91aa0aa327	6
197380	atenolol 25 MG Oral Tablet	SCD	741f328d-21a1-3b19-e053-2a91aa0aa327	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4538-3	68071453803	30 TABLET in 1 BOTTLE (68071-4538-3)	30 tablet	2018-08-23	0000-00-00	No	No	Current
68071-4538-5	68071453805	45 TABLET in 1 BOTTLE (68071-4538-5)	45 tablet	2018-08-23	0000-00-00	No	No	Current
68071-4538-6	68071453806	60 TABLET in 1 BOTTLE (68071-4538-6)	60 tablet	2018-08-23	0000-00-00	No	No	Current
68071-4538-8	68071453808	180 TABLET in 1 BOTTLE (68071-4538-8)	180 tablet	2018-08-23	0000-00-00	No	No	Current
68071-4538-9	68071453809	90 TABLET in 1 BOTTLE (68071-4538-9)	90 tablet	2018-08-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atenolol Tablets USP 25 mg, 50 mg and 100 mg	NuCare Pharmaceuticals,Inc.	2024-06-10	HUMAN PRESCRIPTION DRUG LABEL	6