Atenolol

Product NDC: 43353-834
11-digit product format: 433530834
Labeler code: 43353
Product ID: 43353-834_7eca20ff-75cb-402d-942a-7c4854718687
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: atenolol
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA073457
Marketing category: ANDA
Marketing start: 2014-02-20
Substance: ATENOLOL
Active strength: 50 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
A073457-001	ATENOLOL	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24
A073457-002	ATENOLOL	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26
A073457-003	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A073457-001	AB
A073457-002	AB
A073457-003	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	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073457-002	ATENOLOL	25MG	TABLET / ORAL	AB	1999-04-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073457-003	ATENOLOL	50MG	TABLET / ORAL	AB	1992-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073457-001	ATENOLOL	100MG	TABLET / ORAL	AB	1992-01-24	`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	A073457-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073457-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A073457-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073457-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073457-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073457-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073457-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073457-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A073457-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073457-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073457-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073457-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073457-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073457-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073457-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073457-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073457-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073457-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073457-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073457-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073457-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073457-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073457-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073457-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073457-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073457-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073457-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073457-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073457-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A073457-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073457-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073457-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073457-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073457-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073457-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073457-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073457-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073457-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073457-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073457-001	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	50 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197379	Internal RxNorm lookup
197381	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
b02b4be4-b75c-4153-b402-cf330a077439	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
43353-834-30	Atenolol	30 in 1 BOTTLE, PLASTIC	TABLET	30	2
43353-834-45	Atenolol	45 in 1 BOTTLE, PLASTIC	TABLET	45	2
43353-834-60	Atenolol	90 in 1 BOTTLE, PLASTIC	TABLET	90	2
43353-834-73	Atenolol	135 in 1 BOTTLE, PLASTIC	TABLET	135	2
43353-834-80	Atenolol	180 in 1 BOTTLE, PLASTIC	TABLET	180	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-834-30	EA - Each	43353-834	e3560aac-66de-4702-9fbd-fe3738536e5f	1	2017-12-14
43353-834-45	EA - Each	43353-834	7e9c872f-64c2-43ea-b89a-257d75d86e05	1	2017-12-14
43353-834-60	EA - Each	43353-834	3ce2329b-4a6e-4da9-9818-77b9797bc67c	1	2017-12-14
43353-834-73	EA - Each	43353-834	91faae1a-e6e6-4a78-b08f-29a193e687bc	1	2017-12-14
43353-834-80	EA - Each	43353-834	4df192dd-60e8-4b73-9b4e-5e40e21b9d09	1	2017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-834	ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Current NDC, Legacy NDC, 5 package rows	20171213_b02b4be4-b75c-4153-b402-cf330a077439.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	Cardinal Health 107, LLC	0fadc652-b075-46ec-ae05-beaf7d91ae13	2026-07-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Safecor Health, LLC	35d04cfd-34d4-429c-b990-a6c00137bc77	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Golden State Medical Supply, Inc.	f4f06c00-9024-4e04-a882-0da2b24d8ff7	2026-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Cardinal Health 107, LLC	15c0c2df-f195-45f9-a1e4-1ed2a43c2216	2026-04-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Mylan Pharmaceuticals Inc.	a7048c81-6769-436b-8397-fbaa7489fcdf	2026-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Northwind Health Company, LLC	f318707a-4fb9-604c-e053-2a95a90ae973	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Northwind Health Company, LLC	d9cdc2ed-99bf-0d6a-e053-2a95a90a0262	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Mylan Institutional Inc.	8dd93a47-d14c-49be-9c22-97c0cdbec75a	2025-07-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
ATENOLOL	ATENOLOL	direct rx	b3d9f826-7ed7-1e3b-e053-2995a90ae731	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Aphena Pharma Solutions - Tennessee, LLC	9aef7a49-d21f-4529-8abf-68bdc343bb6c	2022-08-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Proficient Rx LP	e115f27a-6a7c-498c-b4a1-2d4c5716af22	2020-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457
Atenolol	ATENOLOL	Aphena Pharma Solutions - Tennessee, LLC	b02b4be4-b75c-4153-b402-cf330a077439	2017-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073457 application number: ANDA073457 ndc (product): 43353-834

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
197379	atenolol 100 MG Oral Tablet	PSN	b02b4be4-b75c-4153-b402-cf330a077439	2
197381	atenolol 50 MG Oral Tablet	PSN	b02b4be4-b75c-4153-b402-cf330a077439	2
197379	atenolol 100 MG Oral Tablet	SCD	b02b4be4-b75c-4153-b402-cf330a077439	2
197381	atenolol 50 MG Oral Tablet	SCD	b02b4be4-b75c-4153-b402-cf330a077439	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-834-30	43353083430	30 TABLET in 1 BOTTLE, PLASTIC (43353-834-30)	30 tablet	2014-12-27	0000-00-00	No	No	Current
43353-834-45	43353083445	45 TABLET in 1 BOTTLE, PLASTIC (43353-834-45)	45 tablet	2014-11-18	0000-00-00	No	No	Current
43353-834-60	43353083460	90 TABLET in 1 BOTTLE, PLASTIC (43353-834-60)	90 tablet	2014-12-04	0000-00-00	No	No	Current
43353-834-73	43353083473	135 TABLET in 1 BOTTLE, PLASTIC (43353-834-73)	135 tablet	2014-12-04	0000-00-00	No	No	Current
43353-834-80	43353083480	180 TABLET in 1 BOTTLE, PLASTIC (43353-834-80)	180 tablet	2014-11-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atenolol - Aphena Pharma Solutions - Tennessee, LLC	Aphena Pharma Solutions - Tennessee, LLC	2017-12-08	HUMAN PRESCRIPTION DRUG LABEL	2