Atenolol

Product NDC: 53002-1108
Requested package NDC: 53002-1108-6
11-digit product format: 530021108
Labeler code: 53002
Product ID: 53002-1108_2507724a-897f-4cab-bd08-0576e8743e46
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: ANDA074056
Marketing category: ANDA
Marketing start: 2004-11-16
Marketing end: 0000-00-00
Substance: ATENOLOL
Active strength: 25 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53002-1108	53002-1108-6	I	Inactivated by FDA		2026-08-03

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
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.

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	A074056-001	ATENOLOL	50MG	TABLET / ORAL	AB	1995-01-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074056-002	ATENOLOL	100MG	TABLET / ORAL	AB	1995-01-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074056-003	ATENOLOL	25MG	TABLET / ORAL	AB	2004-07-19	`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	A074056-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074056-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A074056-003	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 · 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
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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53002-1108-0	2025-01-30	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-1	2025-01-30	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-3	2025-01-30	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-6	2025-01-30	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-0	2023-06-07	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-1	2023-06-07	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-3	2023-06-07	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-6	2023-06-07	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-0	2023-01-30	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-1	2023-01-30	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-3	2023-01-30	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-6	2023-01-30	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-0	2020-12-15	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-1	2020-12-15	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-3	2020-12-15	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-6	2020-12-15	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-0	2020-01-31	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-1	2020-01-31	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-3	2020-01-31	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-6	2020-01-31	C162847	48780-1	9d75b9d0-f96d-f424-e053-dadaa90a57ce	ATENOLOL TABLETS USP 0787 0752 0753 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53002-1108-0	Atenolol	100 in 1 BOTTLE	TABLET	100	11
53002-1108-1	Atenolol	10 in 1 BOTTLE	TABLET	10	11
53002-1108-3	Atenolol	30 in 1 BOTTLE	TABLET	30	11
53002-1108-6	Atenolol	60 in 1 BOTTLE	TABLET	60	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1108	ATENOLOL TABLET [RPK PHARMACEUTICALS, INC.]	11	Legacy NDC, 4 package rows	20230609_616bf08d-5adf-4d10-9a2e-bcb536b7c2e0.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	616bf08d-5adf-4d10-9a2e-bcb536b7c2e0	11
197380	atenolol 25 MG Oral Tablet	PSN	616bf08d-5adf-4d10-9a2e-bcb536b7c2e0	11
197381	atenolol 50 MG Oral Tablet	PSN	616bf08d-5adf-4d10-9a2e-bcb536b7c2e0	11
197379	atenolol 100 MG Oral Tablet	SCD	616bf08d-5adf-4d10-9a2e-bcb536b7c2e0	11
197380	atenolol 25 MG Oral Tablet	SCD	616bf08d-5adf-4d10-9a2e-bcb536b7c2e0	11
197381	atenolol 50 MG Oral Tablet	SCD	616bf08d-5adf-4d10-9a2e-bcb536b7c2e0	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1108-6	53002110806	60 TABLET in 1 BOTTLE (53002-1108-6)	60 tablet	2018-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ATENOLOL TABLETS USP 0787 0752 0753 Rx only	RPK Pharmaceuticals, Inc.	2023-06-07	HUMAN PRESCRIPTION DRUG LABEL	11