TENORMIN

Product NDC: 52427-431
11-digit product format: 524270431
Labeler code: 52427
Product ID: 52427-431_ecd0de7b-801e-a5d6-01b7-01b89a8f3a78
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Atenolol
Dosage form: TABLET
Route: ORAL
Labeler: Almatica Pharma LLC
Application: NDA018240
Marketing category: NDA
Marketing start: 2015-04-15
Marketing end: 2026-09-01
Substance: ATENOLOL
Active strength: 100 mg/1
Pharmacologic classes: Adrenergic beta-Antagonists [MoA], beta-Adrenergic Blocker [EPC]
NDC exclude flag: No
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	RLD / RS	Approval date
N018240-001	TENORMIN	ATENOLOL	50MG	TABLET / ORAL	AB	RLD, Approved before 1982
N018240-002	TENORMIN	ATENOLOL	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982
N018240-004	TENORMIN	ATENOLOL	25MG	TABLET / ORAL	AB	RLD	1990-04-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018240-001	AB
N018240-002	AB
N018240-004	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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018240-002	TENORMIN	100MG	TABLET / ORAL	AB	RLD, RS, Approved before 1982		`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018240-004	TENORMIN	25MG	TABLET / ORAL	AB	RLD	1990-04-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018240-001	TENORMIN	50MG	TABLET / ORAL	AB	RLD, Approved before 1982		`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N018240-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018240-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N018240-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018240-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018240-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N018240-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018240-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018240-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018240-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018240-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018240-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N018240-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018240-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018240-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018240-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018240-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018240-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018240-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018240-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018240-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018240-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018240-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018240-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018240-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018240-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018240-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018240-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018240-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018240-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018240-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018240-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018240-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N018240-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018240-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018240-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018240-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018240-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018240-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018240-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018240-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: TENORMIN

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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
150750	Internal RxNorm lookup
152414	Internal RxNorm lookup
197379	Internal RxNorm lookup
197380	Internal RxNorm lookup
197381	Internal RxNorm lookup
201322	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
746db603-a6e1-4dc3-c2d8-92314419098c	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
52427-431-90	TENORMIN	90 in 1 BOTTLE	TABLET	90		23

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52427-431-90	EA - Each	52427-431	7a6e403f-bd12-4a8a-b031-288704ba22f8	1	2015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ATENOLOL	ACTIVE INGREDIENT	50VV3VW0TI	TENORMIN (ATENOLOL) TABLET [ALMATICA PHARMA INC.]	12
ATENOLOL	ACTIVE MOIETY	50VV3VW0TI	TENORMIN (ATENOLOL) TABLET [ALMATICA PHARMA INC.]	12
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TENORMIN (ATENOLOL) TABLET [ALMATICA PHARMA INC.]	12
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TENORMIN (ATENOLOL) TABLET [ALMATICA PHARMA INC.]	12
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	TENORMIN (ATENOLOL) TABLET [ALMATICA PHARMA INC.]	12
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TENORMIN (ATENOLOL) TABLET [ALMATICA PHARMA INC.]	12
WATER	INACTIVE INGREDIENT	059QF0KO0R	TENORMIN (ATENOLOL) TABLET [ALMATICA PHARMA INC.]	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52427-431	TENORMIN (ATENOLOL) TABLET [ALMATICA PHARMA LLC]	23	Current NDC, Legacy NDC, 1 package rows	20241122_746db603-a6e1-4dc3-c2d8-92314419098c.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TENORMIN	ATENOLOL	Upsher-Smith Laboratories, LLC	6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018240 application number: NDA018240
TENORMIN	ATENOLOL	Almatica Pharma LLC	746db603-a6e1-4dc3-c2d8-92314419098c	2023-11-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 018240 application number: NDA018240 ndc (product): 52427-431

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	746db603-a6e1-4dc3-c2d8-92314419098c	23
197380	atenolol 25 MG Oral Tablet	PSN	746db603-a6e1-4dc3-c2d8-92314419098c	23
197381	atenolol 50 MG Oral Tablet	PSN	746db603-a6e1-4dc3-c2d8-92314419098c	23
201322	Tenormin 100 MG Oral Tablet	PSN	746db603-a6e1-4dc3-c2d8-92314419098c	23
150750	Tenormin 25 MG Oral Tablet	PSN	746db603-a6e1-4dc3-c2d8-92314419098c	23
152414	Tenormin 50 MG Oral Tablet	PSN	746db603-a6e1-4dc3-c2d8-92314419098c	23
201322	atenolol 100 MG Oral Tablet [Tenormin]	SBD	746db603-a6e1-4dc3-c2d8-92314419098c	23
150750	atenolol 25 MG Oral Tablet [Tenormin]	SBD	746db603-a6e1-4dc3-c2d8-92314419098c	23
152414	atenolol 50 MG Oral Tablet [Tenormin]	SBD	746db603-a6e1-4dc3-c2d8-92314419098c	23
197379	atenolol 100 MG Oral Tablet	SCD	746db603-a6e1-4dc3-c2d8-92314419098c	23
197380	atenolol 25 MG Oral Tablet	SCD	746db603-a6e1-4dc3-c2d8-92314419098c	23
197381	atenolol 50 MG Oral Tablet	SCD	746db603-a6e1-4dc3-c2d8-92314419098c	23
201322	Tenormin 100 MG Oral Tablet	SY	746db603-a6e1-4dc3-c2d8-92314419098c	23
150750	Tenormin 25 MG Oral Tablet	SY	746db603-a6e1-4dc3-c2d8-92314419098c	23
152414	Tenormin 50 MG Oral Tablet	SY	746db603-a6e1-4dc3-c2d8-92314419098c	23

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52427-431-90	52427043190	90 TABLET in 1 BOTTLE (52427-431-90)	90 tablet	2015-04-15	2026-09-01	No	No	Current