Atenolol

Product NDC: 65862-168
Requested package NDC: 65862-168-76
11-digit product format: 658620168
Labeler code: 65862
Product ID: 65862-168_c5b37783-b0a1-4d21-b0cc-69a13cc4d2db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA078512
Marketing category: ANDA
Marketing start: 2007-10-31
Substance: ATENOLOL
Active strength: 25 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

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
unfinished package	package	65862-168	65862-168-76	UNFINISHED	Active or certified unfinished drug listing		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 · 21 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
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 · 123 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078512-002	ATENOLOL	50MG	TABLET / ORAL	AB	2007-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078512-003	ATENOLOL	100MG	TABLET / ORAL	AB	2007-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078512-001	ATENOLOL	25MG	TABLET / ORAL	AB	2007-10-31	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078512-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078512-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078512-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078512-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078512-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078512-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ATENOLOL	25 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197379	Internal RxNorm lookup
197380	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
1b8a4689-3916-4f4b-b54a-bbb4e322d79b	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
65862-168-01	Atenolol	100 in 1 BOTTLE	TABLET	100		13
65862-168-99	Atenolol	1000 in 1 BOTTLE	TABLET	1000		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-168-01	EA - Each	65862-168	06afefef-e7fc-491e-8281-1465757d5fee	1	2012-07-24
65862-168-99	EA - Each	65862-168	2c77efac-b867-4709-8b16-546ba496feb4	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATENOLOL	ACTIVE INGREDIENT	50VV3VW0TI	ATENOLOL TABLET [AUROBINDO PHARMA LIMITED]	7
ATENOLOL	ACTIVE MOIETY	50VV3VW0TI	ATENOLOL TABLET [AUROBINDO PHARMA LIMITED]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATENOLOL TABLET [AUROBINDO PHARMA LIMITED]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ATENOLOL TABLET [AUROBINDO PHARMA LIMITED]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATENOLOL TABLET [AUROBINDO PHARMA LIMITED]	7
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	ATENOLOL TABLET [AUROBINDO PHARMA LIMITED]	7
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATENOLOL TABLET [AUROBINDO PHARMA LIMITED]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ATENOLOL TABLET [AUROBINDO PHARMA LIMITED]	7
ATENOLOL	ACTIVE INGREDIENT	50VV3VW0TI	ATENOLOL TABLET [MED-HEALTH PHARMA, LLC]	3
ATENOLOL	ACTIVE INGREDIENT	50VV3VW0TI	ATENOLOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
ATENOLOL	ACTIVE MOIETY	50VV3VW0TI	ATENOLOL TABLET [MED-HEALTH PHARMA, LLC]	3
ATENOLOL	ACTIVE MOIETY	50VV3VW0TI	ATENOLOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATENOLOL TABLET [MED-HEALTH PHARMA, LLC]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ATENOLOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ATENOLOL TABLET [MED-HEALTH PHARMA, LLC]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ATENOLOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATENOLOL TABLET [MED-HEALTH PHARMA, LLC]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ATENOLOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	ATENOLOL TABLET [MED-HEALTH PHARMA, LLC]	3
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	ATENOLOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATENOLOL TABLET [MED-HEALTH PHARMA, LLC]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ATENOLOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ATENOLOL TABLET [MED-HEALTH PHARMA, LLC]	3
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ATENOLOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-168	ATENOLOL TABLET [AUROBINDO PHARMA LIMITED]	13	Current NDC, Legacy NDC, 2 package rows	20240224_1b8a4689-3916-4f4b-b54a-bbb4e322d79b.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	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	REMEDYREPACK INC.	4ca8dd77-cdac-41fe-a742-b1b32551203b	2026-02-17	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	REMEDYREPACK INC.	cdca0ef8-2ac3-4430-a662-f88522f68d8e	2025-09-25	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 ndc (product): 65862-168
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	1b8a4689-3916-4f4b-b54a-bbb4e322d79b	13
197380	atenolol 25 MG Oral Tablet	PSN	1b8a4689-3916-4f4b-b54a-bbb4e322d79b	13
197381	atenolol 50 MG Oral Tablet	PSN	1b8a4689-3916-4f4b-b54a-bbb4e322d79b	13
197379	atenolol 100 MG Oral Tablet	SCD	1b8a4689-3916-4f4b-b54a-bbb4e322d79b	13
197380	atenolol 25 MG Oral Tablet	SCD	1b8a4689-3916-4f4b-b54a-bbb4e322d79b	13
197381	atenolol 50 MG Oral Tablet	SCD	1b8a4689-3916-4f4b-b54a-bbb4e322d79b	13
197380	atenolol 25 MG Oral Tablet	PSN	f5c86a73-70b6-46b2-ad9a-272c8d4673e9	8
197380	atenolol 25 MG Oral Tablet	SCD	f5c86a73-70b6-46b2-ad9a-272c8d4673e9	8
197380	atenolol 25 MG Oral Tablet	PSN	2ae158bb-aa03-4b44-916b-1fcfc84b4fd0	6
197380	atenolol 25 MG Oral Tablet	SCD	2ae158bb-aa03-4b44-916b-1fcfc84b4fd0	6
197379	atenolol 100 MG Oral Tablet	PSN	27522eb0-9e11-45cb-9137-fc50dc78ba80	3
197379	atenolol 100 MG Oral Tablet	PSN	97ec87b2-322a-438b-ba95-69040c580eb6	3
197380	atenolol 25 MG Oral Tablet	PSN	f31b11ed-2ff6-5cfc-e053-2a95a90af2ca	3
197380	atenolol 25 MG Oral Tablet	PSN	4555261d-a997-4aa5-aba8-81aac7033787	3
197380	atenolol 25 MG Oral Tablet	PSN	97ec87b2-322a-438b-ba95-69040c580eb6	3
197380	atenolol 25 MG Oral Tablet	PSN	27522eb0-9e11-45cb-9137-fc50dc78ba80	3
197381	atenolol 50 MG Oral Tablet	PSN	97ec87b2-322a-438b-ba95-69040c580eb6	3
197381	atenolol 50 MG Oral Tablet	PSN	27522eb0-9e11-45cb-9137-fc50dc78ba80	3
197379	atenolol 100 MG Oral Tablet	SCD	97ec87b2-322a-438b-ba95-69040c580eb6	3
197379	atenolol 100 MG Oral Tablet	SCD	27522eb0-9e11-45cb-9137-fc50dc78ba80	3
197380	atenolol 25 MG Oral Tablet	SCD	97ec87b2-322a-438b-ba95-69040c580eb6	3
197380	atenolol 25 MG Oral Tablet	SCD	4555261d-a997-4aa5-aba8-81aac7033787	3
197380	atenolol 25 MG Oral Tablet	SCD	f31b11ed-2ff6-5cfc-e053-2a95a90af2ca	3
197380	atenolol 25 MG Oral Tablet	SCD	27522eb0-9e11-45cb-9137-fc50dc78ba80	3
197381	atenolol 50 MG Oral Tablet	SCD	97ec87b2-322a-438b-ba95-69040c580eb6	3
197381	atenolol 50 MG Oral Tablet	SCD	27522eb0-9e11-45cb-9137-fc50dc78ba80	3
197380	atenolol 25 MG Oral Tablet	PSN	50762eee-e139-4d7f-e063-6294a90a777c	1
197380	atenolol 25 MG Oral Tablet	SCD	50762eee-e139-4d7f-e063-6294a90a777c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Status
65862-168-76	65862016876	13000 TABLET in 1 BAG (65862-168-76)	13000 tablet	31-OCT-07	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Atenolol Tablets, USP Rx only	Coupler LLC	2026-04-27	HUMAN PRESCRIPTION DRUG LABEL	1
Atenolol Tablets, USP Rx only	REMEDYREPACK INC.	2026-04-13	HUMAN PRESCRIPTION DRUG LABEL	8
Atenolol Tablets, USP Rx only	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	3
Atenolol Tablets, USP Rx only	Major Pharmaceuticals	2025-02-03	HUMAN PRESCRIPTION DRUG LABEL	3
Atenolol Tablets, USP Rx only	Preferred Pharmaceuticals Inc.	2024-11-06	HUMAN PRESCRIPTION DRUG LABEL	6
Atenolol Tablets, USP Rx only	Aurobindo Pharma Limited \| Aurolife Pharma LLC	2024-02-21	Human Prescription Drug Label	13
Atenolol Tablets, USP Rx only	Correct Rx Pharmacy Services, Inc.	2024-02-06	HUMAN PRESCRIPTION DRUG LABEL	1
Atenolol Tablets, USP	Med-Health Pharma, LLC	2011-09-19	Human Prescription Drug Label	3
Atenolol Tablets, USP	State of Florida DOH Central Pharmacy	2010-08-18	HUMAN PRESCRIPTION DRUG LABEL	3