Atenolol

Product NDC: 0781-1506
Requested package NDC: 0781-1506-01
11-digit product format: 007811506
Labeler code: 0781
Product ID: 0781-1506_1e5460cc-8e8d-44cf-b14b-7129a0e95122
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol
Dosage form: TABLET
Route: ORAL
Labeler: Sandoz Inc
Application: ANDA073025
Marketing category: ANDA
Marketing start: 1991-09-17
Marketing end: 2021-12-31
Substance: ATENOLOL
Active strength: 50 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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	0781-1506	0781-1506-01	D	Discontinued by firm		2026-08-03

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog.

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
2019-12-13 00:20 UTC	2019-12	A073025-001	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A073025-001	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073025-001	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073025-001	ATENOLOL	50MG	TABLET / ORAL	AB	1991-09-17	`ea99ee380514…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A073025-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A073025-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073025-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073025-001	AB	1	`ea99ee380514…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-1506-01	EA - Each	0781-1506	4c2ce85a-f951-44ac-8d1a-a62e0d603a6a	1	2012-07-24
0781-1506-10	EA - Each	0781-1506	5c625b76-c722-4b87-a86f-02ba37f25673	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATENOLOL	ACTIVE INGREDIENT	50VV3VW0TI	ATENOLOL TABLET [READYMEDS]	15
ATENOLOL	ACTIVE INGREDIENT	50VV3VW0TI	ATENOLOL TABLET [SANDOZ INC]	15
ATENOLOL	ACTIVE MOIETY	50VV3VW0TI	ATENOLOL TABLET [READYMEDS]	15
ATENOLOL	ACTIVE MOIETY	50VV3VW0TI	ATENOLOL TABLET [SANDOZ INC]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATENOLOL TABLET [READYMEDS]	15
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATENOLOL TABLET [SANDOZ INC]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATENOLOL TABLET [READYMEDS]	15
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATENOLOL TABLET [SANDOZ INC]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATENOLOL TABLET [READYMEDS]	15
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATENOLOL TABLET [SANDOZ INC]	15
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ATENOLOL TABLET [READYMEDS]	15
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ATENOLOL TABLET [SANDOZ INC]	15
ATENOLOL	ACTIVE INGREDIENT	50VV3VW0TI	ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
ATENOLOL	ACTIVE MOIETY	50VV3VW0TI	ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
atenolol	ACTIVE INGREDIENT	50VV3VW0TI	ATENOLOL TABLET [CONTRACT PHARMACY SERVICES-PA]	1
ATENOLOL	ACTIVE INGREDIENT	50VV3VW0TI	ATENOLOL TABLET [PROFICIENT RX LP]	1
ATENOLOL	ACTIVE INGREDIENT	50VV3VW0TI	ATENOLOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
atenolol	ACTIVE MOIETY	50VV3VW0TI	ATENOLOL TABLET [CONTRACT PHARMACY SERVICES-PA]	1
ATENOLOL	ACTIVE MOIETY	50VV3VW0TI	ATENOLOL TABLET [PROFICIENT RX LP]	1
ATENOLOL	ACTIVE MOIETY	50VV3VW0TI	ATENOLOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATENOLOL TABLET [PROFICIENT RX LP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATENOLOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATENOLOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATENOLOL TABLET [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATENOLOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATENOLOL TABLET [PROFICIENT RX LP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ATENOLOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ATENOLOL TABLET [PROFICIENT RX LP]	1

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
197380	atenolol 25 MG Oral Tablet	PSN	bfe631e8-ab7d-40d0-b42e-ed1102955c44	15
197381	atenolol 50 MG Oral Tablet	PSN	bfe631e8-ab7d-40d0-b42e-ed1102955c44	15
197380	atenolol 25 MG Oral Tablet	SCD	bfe631e8-ab7d-40d0-b42e-ed1102955c44	15
197381	atenolol 50 MG Oral Tablet	SCD	bfe631e8-ab7d-40d0-b42e-ed1102955c44	15
197379	atenolol 100 MG Oral Tablet	PSN	e6611d33-f4c7-40c4-8db8-6f43c85d444c	11
197381	atenolol 50 MG Oral Tablet	PSN	e6611d33-f4c7-40c4-8db8-6f43c85d444c	11
197379	atenolol 100 MG Oral Tablet	SCD	e6611d33-f4c7-40c4-8db8-6f43c85d444c	11
197381	atenolol 50 MG Oral Tablet	SCD	e6611d33-f4c7-40c4-8db8-6f43c85d444c	11
197381	atenolol 50 MG Oral Tablet	PSN	00478eeb-f1c8-4355-a7c3-81c340b557d8	1
197381	atenolol 50 MG Oral Tablet	PSN	a2d29601-21aa-4e78-a725-6c1ea982e3ac	1
197381	atenolol 50 MG Oral Tablet	SCD	00478eeb-f1c8-4355-a7c3-81c340b557d8	1
197381	atenolol 50 MG Oral Tablet	SCD	a2d29601-21aa-4e78-a725-6c1ea982e3ac	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-1506-01	00781150601	100 TABLET in 1 BOTTLE (0781-1506-01)	100 tablet	1991-09-17	2021-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atenolol Tablets, USP	REMEDYREPACK INC.	2021-03-12	HUMAN PRESCRIPTION DRUG LABEL	5
Atenolol Tablets, USP	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Atenolol Tablets, USP	Bryant Ranch Prepack	2020-01-19	HUMAN PRESCRIPTION DRUG LABEL	2
Atenolol Tablets, USP	A-S Medication Solutions	2020-01-18	HUMAN PRESCRIPTION DRUG LABEL	11
Atenolol Tablets, USP	Bryant Ranch Prepack	2019-10-01	HUMAN PRESCRIPTION DRUG LABEL	4
Atenolol Tablets, USP	Sandoz Inc	2019-07-23	HUMAN PRESCRIPTION DRUG LABEL	16
Atenolol Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2019-04-17	HUMAN PRESCRIPTION DRUG LABEL	3
Atenolol Tablets, USP	State of Florida DOH Central Pharmacy	2014-12-07	HUMAN PRESCRIPTION DRUG LABEL	1
Atenolol Tablets, USP	ReadyMeds	2014-07-02	HUMAN PRESCRIPTION DRUG LABEL	15
Atenolol Tablets, USP	Contract Pharmacy Services-PA	2010-04-07	HUMAN PRESCRIPTION DRUG LABEL	1