Atenolol

Product NDC: 66267-029
11-digit product format: 662670029
Labeler code: 66267
Product ID: 66267-029_27353cec-1f04-8a8b-e063-6394a90af48e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals, Inc.
Application: ANDA076900
Marketing category: ANDA
Marketing start: 2005-10-08
Substance: ATENOLOL
Active strength: 100 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 1.

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A076900-001	ATENOLOL	25MG	TABLET / ORAL	AB	2005-01-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076900-002	ATENOLOL	50MG	TABLET / ORAL	AB	2005-01-28	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076900-003	ATENOLOL	100MG	TABLET / ORAL	AB	2005-01-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A076900-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076900-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A076900-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 66267-029
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
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

Additional Listing Data#

Finished product: Yes
Brand name base: Atenolol
Listing expiration: 2026-12-31

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
3d70576a-6fa7-481d-e054-00144ff88e88	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
faf41ef3-b4b3-a29e-3b26-07c3009003bf	Product name	5	20220517
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
5eb1a708-d713-e905-0a08-b103c64796f4	Product name	3	20201019
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66267-029-30	Atenolol	30 in 1 BOTTLE	TABLET	30	5
66267-029-60	Atenolol	60 in 1 BOTTLE	TABLET	60	5
66267-029-90	Atenolol	90 in 1 BOTTLE	TABLET	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66267-029-30	EA - Each	66267-029	4e4bf41a-fa14-49fa-8241-e5bce0cca684	1	2016-10-06
66267-029-60	EA - Each	66267-029	09cdab03-b27c-4c71-b6e9-e6c96d22009b	1	2016-10-06
66267-029-90	EA - Each	66267-029	7ef9df35-5a65-483d-b4be-57e834125362	1	2016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66267-029	ATENOLOL TABLET [NUCARE PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 3 package rows	20241120_3d70576a-6fa7-481d-e054-00144ff88e88.zip

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	3d70576a-6fa7-481d-e054-00144ff88e88	5
197379	atenolol 100 MG Oral Tablet	SCD	3d70576a-6fa7-481d-e054-00144ff88e88	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
66267-029-30	66267002930	30 TABLET in 1 BOTTLE (66267-029-30)	30 tablet	2016-09-26	No	No	Current
66267-029-60	66267002960	60 TABLET in 1 BOTTLE (66267-029-60)	60 tablet	2016-09-26	No	No	Current
66267-029-90	66267002990	90 TABLET in 1 BOTTLE (66267-029-90)	90 tablet	2016-09-26	No	No	Current