Atenolol

Product NDC: 71335-0912
11-digit product format: 713350912
Labeler code: 71335
Product ID: 71335-0912_16ec3f65-85d8-4c9a-b25c-da4af3e24463
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA076900
Marketing category: ANDA
Marketing start: 2005-10-08
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 7 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
Dataset	Scope	Package NDC
excluded product	product
excluded package	package	71335-0912-1
excluded package	package	71335-0912-4
excluded package	package	71335-0912-5
excluded package	package	71335-0912-2
excluded package	package	71335-0912-6
excluded package	package	71335-0912-3

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
A076900-001	ATENOLOL	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28
A076900-002	ATENOLOL	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28
A076900-003	ATENOLOL	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076900-001	AB
A076900-002	AB
A076900-003	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	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`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	A076900-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076900-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076900-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076900-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076900-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076900-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076900-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076900-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076900-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076900-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076900-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076900-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076900-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076900-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076900-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076900-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076900-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076900-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076900-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076900-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076900-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076900-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076900-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076900-001	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	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
67d9ca94-2af6-4ebb-a5c3-8d360f741277	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
71335-0912-1	Atenolol	30 in 1 BOTTLE	TABLET	30	7
71335-0912-2	Atenolol	100 in 1 BOTTLE	TABLET	100	7
71335-0912-3	Atenolol	60 in 1 BOTTLE	TABLET	60	7
71335-0912-4	Atenolol	90 in 1 BOTTLE	TABLET	90	7
71335-0912-5	Atenolol	20 in 1 BOTTLE	TABLET	20	7
71335-0912-6	Atenolol	10 in 1 BOTTLE	TABLET	10	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0912	ATENOLOL TABLET [BRYANT RANCH PREPACK]	7	Current NDC, Legacy NDC, 6 package rows	20240918_67d9ca94-2af6-4ebb-a5c3-8d360f741277.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atenolol	ATENOLOL	A-S Medication Solutions	b6fe1a12-a6d5-4c4c-9d77-6f717b43f8fe	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	A-S Medication Solutions	d21f2b4d-6584-48e5-8045-e5927ba03329	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	PD-Rx Pharmaceuticals, Inc.	8acdb229-928b-4c22-88f1-f4dd97cde274	2025-10-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	PD-Rx Pharmaceuticals, Inc.	bdbf6779-8e9b-4ce1-a361-ede4914dd2f3	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	American Health Packaging	d19e9fcf-dfa1-43d7-94dc-e3f03fb90f5c	2024-12-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	Zydus Lifesciences Limited	2492d5f6-00b0-42c9-a793-2be83ea81ad1	2024-11-25		Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	NuCare Pharmaceuticals, Inc.	3d70576a-6fa7-481d-e054-00144ff88e88	2024-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900
Atenolol	ATENOLOL	Bryant Ranch Prepack	67d9ca94-2af6-4ebb-a5c3-8d360f741277	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900 ndc (product): 71335-0912
Atenolol	ATENOLOL	Zydus Pharmaceuticals USA Inc.	db801706-1362-44c7-92ab-f584f96c7e1c	2024-01-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076900 application number: ANDA076900

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	67d9ca94-2af6-4ebb-a5c3-8d360f741277	7
197381	atenolol 50 MG Oral Tablet	PSN	67d9ca94-2af6-4ebb-a5c3-8d360f741277	7
197379	atenolol 100 MG Oral Tablet	SCD	67d9ca94-2af6-4ebb-a5c3-8d360f741277	7
197381	atenolol 50 MG Oral Tablet	SCD	67d9ca94-2af6-4ebb-a5c3-8d360f741277	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0912-1	71335091201	30 TABLET in 1 BOTTLE (71335-0912-1)	30 tablet	2016-02-17	0000-00-00	No	No	Current
71335-0912-2	71335091202	100 TABLET in 1 BOTTLE (71335-0912-2)	100 tablet	2016-02-17	0000-00-00	No	No	Current
71335-0912-3	71335091203	60 TABLET in 1 BOTTLE (71335-0912-3)	60 tablet	2016-02-17	0000-00-00	No	No	Current
71335-0912-4	71335091204	90 TABLET in 1 BOTTLE (71335-0912-4)	90 tablet	2016-02-17	0000-00-00	No	No	Current
71335-0912-5	71335091205	20 TABLET in 1 BOTTLE (71335-0912-5)	20 tablet	2016-02-17	0000-00-00	No	No	Current
71335-0912-6	71335091206	10 TABLET in 1 BOTTLE (71335-0912-6)	10 tablet	2016-02-17	0000-00-00	No	No	Current