Atenolol

Product NDC: 71610-857
Requested package NDC: 71610-857-60
11-digit product format: 716100857
Labeler code: 71610
Product ID: 71610-857_251464ff-eeae-0b0f-e063-6394a90ae341
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA074056
Marketing category: ANDA
Marketing start: 2004-11-16
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 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074056-002	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074056-003	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A074056-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074056-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074056-003	AB	1	`84e616aacf4f…`
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…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
23e96396-85d3-0d8e-e063-6394a90a614d	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
71610-857-30	Atenolol	30 in 1 BOTTLE	TABLET	30	2
71610-857-45	Atenolol	45 in 1 BOTTLE	TABLET	45	2
71610-857-53	Atenolol	60 in 1 BOTTLE	TABLET	60	2
71610-857-60	Atenolol	90 in 1 BOTTLE	TABLET	90	2
71610-857-80	Atenolol	180 in 1 BOTTLE	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
71610-857-30	EA - Each	71610-857	1610aabc-671c-41fc-a29e-f9c7b6d4ed9e	1	2024-12-10
71610-857-45	EA - Each	71610-857	656c1c23-7d0b-46bb-9454-e7df6a295aa8	1	2024-12-10
71610-857-53	EA - Each	71610-857	936c00e8-5a41-450c-aba7-5b3693a01a5f	1	2024-12-10
71610-857-60	EA - Each	71610-857	2b1cfb9d-e4b2-4a1f-9bea-c919fcb295ab	1	2024-12-10
71610-857-80	EA - Each	71610-857	cf6d97b3-66a3-4366-ae16-11f0e04a4146	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-857	ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]	2	Current NDC, 5 package rows	20241024_23e96396-85d3-0d8e-e063-6394a90a614d.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
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 ndc (package): 71610-857-60 ndc (product): 71610-857 ndc11 (package): 71610085760
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
197380	atenolol 25 MG Oral Tablet	PSN	23e96396-85d3-0d8e-e063-6394a90a614d	2
197380	atenolol 25 MG Oral Tablet	SCD	23e96396-85d3-0d8e-e063-6394a90a614d	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71610-857-60	71610085760	90 TABLET in 1 BOTTLE (71610-857-60)	90 tablet	2024-10-04	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ATENOLOL TABLETS USP Rx only	Aphena Pharma Solutions - Tennessee, LLC	2024-10-22	HUMAN PRESCRIPTION DRUG LABEL	2