Atenolol

Product NDC: 70518-4099
Requested package NDC: 70518-4099-0
11-digit product format: 705184099
Labeler code: 70518
Product ID: 70518-4099_5a09234e-af4d-b46a-e063-6294a90a794c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA078512
Marketing category: ANDA
Marketing start: 2024-06-12
Substance: ATENOLOL
Active strength: 100 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
A078512-001	ATENOLOL	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31
A078512-002	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31
A078512-003	ATENOLOL	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078512-001	AB
A078512-002	AB
A078512-003	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	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`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	A078512-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078512-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078512-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078512-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078512-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078512-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078512-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078512-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078512-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078512-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078512-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078512-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078512-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078512-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078512-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078512-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078512-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078512-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078512-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078512-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078512-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078512-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078512-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078512-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078512-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078512-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078512-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078512-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078512-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078512-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078512-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078512-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078512-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078512-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078512-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078512-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078512-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078512-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078512-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078512-001	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	100 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
197379	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
cdca0ef8-2ac3-4430-a662-f88522f68d8e	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	Strength	SPL version
70518-4099-0	Atenolol	90 in 1 BOTTLE, PLASTIC	TABLET	90		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-4099	ATENOLOL (ATENOLOL) TABLET [REMEDYREPACK INC.]	1	Current NDC, 1 package rows	20240613_cdca0ef8-2ac3-4430-a662-f88522f68d8e.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	REMEDYREPACK INC.	cdca0ef8-2ac3-4430-a662-f88522f68d8e	2026-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512 ndc (package): 70518-4099-0 ndc (product): 70518-4099 ndc11 (package): 70518409900
Atenolol	ATENOLOL	REMEDYREPACK INC.	4ca8dd77-cdac-41fe-a742-b1b32551203b	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Coupler LLC	5126a70e-632d-e626-e063-6394a90ab791	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Coupler LLC	50760735-9305-0bbf-e063-6294a90a5b4c	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Coupler LLC	50762eee-e139-4d7f-e063-6294a90a777c	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	REMEDYREPACK INC.	f5c86a73-70b6-46b2-ad9a-272c8d4673e9	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Northwind Health Company, LLC	f31b11ed-2ff6-5cfc-e053-2a95a90af2ca	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Northwind Health Company, LLC	f76d03b8-f8d6-59b8-e053-6394a90a3a3f	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Northwind Health Company, LLC	f2b335b4-93d2-0459-e053-2a95a90a1a5b	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	QPharma Inc	f682a775-2255-05e2-e053-2a95a90ac3f3	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	331128cc-f56e-4329-e063-6394a90a5ead	2025-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	NuCare Pharmaceuticals,Inc.	410c48ae-582a-2ab2-e063-6294a90af27c	2025-10-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	0f744371-94fa-419d-bfed-b22301dde8b8	2025-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Major Pharmaceuticals	4555261d-a997-4aa5-aba8-81aac7033787	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Bryant Ranch Prepack	09b21985-1818-449d-9b29-98f733cf7b9f	2024-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Preferred Pharmaceuticals Inc.	2ae158bb-aa03-4b44-916b-1fcfc84b4fd0	2024-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	Aurobindo Pharma Limited	1b8a4689-3916-4f4b-b54a-bbb4e322d79b	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	A-S Medication Solutions	a0e3b2a5-5ea1-4549-8144-bd059f7966f0	2023-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512
Atenolol	ATENOLOL	A-S Medication Solutions	98471493-56ee-47a4-9120-0975c265361e	2023-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078512 application number: ANDA078512

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	cdca0ef8-2ac3-4430-a662-f88522f68d8e	2
197379	atenolol 100 MG Oral Tablet	SCD	cdca0ef8-2ac3-4430-a662-f88522f68d8e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70518-4099-0	70518409900	90 TABLET in 1 BOTTLE, PLASTIC (70518-4099-0)	90 tablet	2024-06-12	No	No	Current