Atenolol

Product NDC: 60760-925
11-digit product format: 607600925
Labeler code: 60760
Product ID: 60760-925_59f41c37-b397-6bba-e063-6294a90a0c07
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol
Dosage form: TABLET
Route: ORAL
Labeler: St. Mary's Medical Park Pharmacy
Application: ANDA213136
Marketing category: ANDA
Marketing start: 2026-08-25
Substance: ATENOLOL
Active strength: 50 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
A213136-001	ATENOLOL	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21
A213136-002	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21
A213136-003	ATENOLOL	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213136-001	AB
A213136-002	AB
A213136-003	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 3 · 120 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	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213136-002	ATENOLOL	50MG	TABLET / ORAL	AB	2019-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213136-003	ATENOLOL	100MG	TABLET / ORAL	AB	2019-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213136-001	ATENOLOL	25MG	TABLET / ORAL	AB	2019-11-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 120 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	A213136-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213136-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213136-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213136-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213136-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213136-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213136-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213136-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213136-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213136-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213136-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213136-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213136-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213136-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213136-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213136-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213136-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213136-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213136-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213136-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213136-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213136-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213136-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213136-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213136-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213136-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213136-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213136-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213136-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213136-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213136-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213136-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213136-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213136-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213136-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213136-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213136-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213136-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213136-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213136-001	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: 2027-12-31

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
59f418e6-47db-6a71-e063-6294a90a632c	Available on FDA.report

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	REMEDYREPACK INC.	897e18f6-3b57-4ef0-85ff-9dfa23521eb9	2026-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	St. Mary's Medical Park Pharmacy	59f418e6-47db-6a71-e063-6294a90a632c	2026-08-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136 ndc (product): 60760-925
Atenolol	ATENOLOL	ASCLEMED USA INC.	2ee7b7da-303d-4a57-a1eb-25e8923660c0	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	0ad0c7dd-e4e5-4968-9372-7a9bb30073ec	2026-04-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	5ad1426a-5a74-427b-812d-c7b144c84474	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	A-S Medication Solutions	d7a93c64-0c52-4d72-a9be-37c7ca355cdf	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	Bryant Ranch Prepack	290f4de3-8815-466c-81dc-8bc632375896	2025-10-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	A-S Medication Solutions	3d35592c-91ac-44f6-b077-5963e952f0dd	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	A-S Medication Solutions	f419c72e-f1f9-4b5a-94ff-a525367cdce4	2025-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	A-S Medication Solutions	d3e72119-e3c3-41ba-8787-acc86b44d6c4	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	A-S Medication Solutions	a3c8d507-e040-409e-9f97-742925cc66a1	2025-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol 29300-411	ATENOLOL	NuCare Pharmaceuticals,Inc.	239b1cce-3b1a-f049-e063-6394a90a0e0a	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	Quality Care Products, LLC	4fc4a969-286f-4fd2-b16a-f0291fd1c5c0	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	Bryant Ranch Prepack	bd0f7f1c-dd20-4de6-a012-f581a216f23f	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136
Atenolol	ATENOLOL	Unichem Pharmaceuticals (USA), Inc.	35d99c43-7305-4a4a-886e-a9bf3ee88fa8	2024-01-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213136 application number: ANDA213136

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
50VV3VW0TI	ATENOLOL	29122-68-7	ATENOLOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
60760-925-30	60760092530	30 TABLET in 1 BOTTLE, PLASTIC (60760-925-30)	30 tablet	2026-08-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atenolol Tablets, USP Rx only	St. Mary's Medical Park Pharmacy	2026-08-25	HUMAN PRESCRIPTION DRUG LABEL	1