Atenolol

Product NDC: 42708-012
11-digit product format: 427080012
Labeler code: 42708
Product ID: 42708-012_45b43876-f7b3-e3e8-e063-6394a90ad40a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol
Dosage form: TABLET
Route: ORAL
Labeler: QPharma, Inc.
Application: ANDA074056
Marketing category: ANDA
Marketing start: 1995-02-22
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 42.

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
A074056-001	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18
A074056-002	ATENOLOL	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18
A074056-003	ATENOLOL	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074056-001	AB
A074056-002	AB
A074056-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074056-002	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074056-003	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074056-002	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074056-003	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074056-002	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074056-003	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074056-002	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074056-003	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074056-002	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074056-003	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074056-002	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074056-003	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074056-002	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074056-003	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074056-002	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074056-003	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074056-002	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074056-003	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074056-002	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074056-003	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074056-002	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074056-003	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074056-002	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074056-003	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074056-002	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074056-003	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074056-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074056-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074056-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074056-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074056-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074056-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074056-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074056-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074056-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074056-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074056-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074056-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074056-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074056-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074056-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074056-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074056-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074056-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074056-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074056-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074056-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074056-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074056-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074056-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074056-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074056-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074056-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074056-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074056-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074056-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074056-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074056-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074056-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074056-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074056-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074056-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074056-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074056-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074056-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074056-001	AB	1	`1e350fbaab3a…`

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
70d7a585-7a46-4eac-b2b5-2ac5b98d9882	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42708-012-30	2021-03-12	C162847	48780-1	ba0f9c33-117f-a910-e053-dadaa90a0b85	ATENOLOL TABLETS USP Rx only
42708-012-30	2021-01-29	C162847	48780-1	ba0f9c33-117f-a910-e053-dadaa90a0b85	ATENOLOL TABLETS USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42708-012-30	Atenolol	30 in 1 BOTTLE	TABLET	30		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42708-012	ATENOLOL TABLET [QPHARMA, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20241128_70d7a585-7a46-4eac-b2b5-2ac5b98d9882.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	QPharma, Inc.	70d7a585-7a46-4eac-b2b5-2ac5b98d9882	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074056 application number: ANDA074056 ndc (product): 42708-012
Atenolol	ATENOLOL	PD-Rx Pharmaceuticals, Inc.	95761173-1c95-46b2-a08f-fbc3e70daba8	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074056 application number: ANDA074056
Atenolol	ATENOLOL	PD-Rx Pharmaceuticals, Inc.	c69b8e5e-c7c3-4883-9cea-f7f435a8ede8	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074056 application number: ANDA074056
Atenolol	ATENOLOL	Aphena Pharma Solutions - Tennessee, LLC	23e96396-85d3-0d8e-e063-6394a90a614d	2024-10-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074056 application number: ANDA074056
Atenolol	ATENOLOL	Aphena Pharma Solutions - Tennessee, LLC	247569d6-9a73-f1d0-e063-6394a90a667a	2024-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074056 application number: ANDA074056
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	7366c6f8-4cb3-520e-e053-2991aa0a2cc8	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074056 application number: ANDA074056
Atenolol	ATENOLOL	Teva Pharmaceuticals USA, Inc.	25a72ec9-de0f-44e5-90b8-da1aab0d3588	2024-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074056 application number: ANDA074056
Atenolol	ATENOLOL	A-S Medication Solutions	d73a475a-c8c9-44a0-89ac-6a2d665c0d24	2023-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074056 application number: ANDA074056
Atenolol	ATENOLOL	Proficient Rx LP	24f1f3f4-bbda-458b-b15f-d942c90534e2	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074056 application number: ANDA074056
Atenolol	ATENOLOL	Bryant Ranch Prepack	ba0b0221-d4b3-4cb1-9435-53a75fcc4b40	2020-07-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074056 application number: ANDA074056
Atenolol	ATENOLOL	Proficient Rx LP	b198b34c-861a-4b52-b4df-8c48b807520a	2020-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074056 application number: ANDA074056

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	70d7a585-7a46-4eac-b2b5-2ac5b98d9882	6
197381	atenolol 50 MG Oral Tablet	SCD	70d7a585-7a46-4eac-b2b5-2ac5b98d9882	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42708-012-30	42708001230	30 TABLET in 1 BOTTLE (42708-012-30)	30 tablet	2018-03-14	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ATENOLOL TABLETS USP Rx only	QPharma, Inc. \| Teva Pharmaceuticals USA, Inc. \| Northwind Health Company, LLC	2025-12-05	HUMAN PRESCRIPTION DRUG LABEL	6