Atenolol

Product NDC
64980-437
11-digit product format
649800437
Labeler code
64980
Product ID
64980-437_7bf7d854-7736-4159-81e0-2f9f0c12d73c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA077443
Marketing category
ANDA
Marketing start
2010-06-10
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

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077443-001ATENOLOLATENOLOL25MGTABLET / ORALAB2006-09-13
A077443-002ATENOLOLATENOLOL50MGTABLET / ORALAB2006-09-13
A077443-003ATENOLOLATENOLOL100MGTABLET / ORALAB2006-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077443-001AB
A077443-002AB
A077443-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-138072bd15b7f6…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077443-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077443-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077443-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077443-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATENOLOL25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
50VV3VW0TIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197379Internal RxNorm lookup
197380Internal RxNorm lookup
197381Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
96dd038f-b363-4e24-9c67-82b7c85c3bc4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
faf41ef3-b4b3-a29e-3b26-07c3009003bfProduct name520220517
5eb1a708-d713-e905-0a08-b103c64796f4Product name320201019

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-437-01Atenolol100 in 1 BOTTLETABLET1005
64980-437-10Atenolol1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-437-01EA - Each64980-437e376523e-01bf-4c09-8299-a69a08e5178112018-02-20
64980-437-10EA - Each64980-437d7c79262-62b2-4e59-9108-3ab4ff5e425212018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-437ATENOLOL TABLET [RISING PHARMA HOLDINGS, INC.]4Current NDC, Legacy NDC, 2 package rows20240529_96dd038f-b363-4e24-9c67-82b7c85c3bc4.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLSt. Mary's Medical Park Pharmacy7f8304a4-93de-774f-e053-2a91aa0aa5b52026-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLSt Mary's Medical Park Pharmacy78d394b8-8ffb-a846-e053-2991aa0aa58c2026-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLSt. Mary's Medical Park Pharmacy8501f6c1-8157-4189-e053-2a91aa0ac4ef2026-06-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLPreferred Pharmaceuticals, Inc.26d3df38-20c6-40e0-a456-da4f10fff6322026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLPreferred Pharmaceuticals, Inc.a8d48a47-ccab-4a35-a092-6e562683ade32026-03-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLPreferred Pharmaceuticals Inc.82100fc8-5a5a-4d80-8101-72024ee0abef2026-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
atenololATENOLOLdirect rxb3c757de-1cbf-61f5-e053-2995a90accfc2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLA-S Medication Solutions43acd912-f0f4-47eb-b81f-cbbfed77c5572026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLA-S Medication Solutionse4ece8f4-3714-42ba-b36d-d00586dfd33a2026-01-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLNorthwind Health Company, LLCdb5bd8e2-1314-0f7f-e053-2995a90ae86e2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLQPharma, Inc.bd43e0b1-c05e-01ae-e053-2a95a90af1cd2025-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLRising Pharma Holdings, Inc.96dd038f-b363-4e24-9c67-82b7c85c3bc42025-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
ndc (product): 64980-437
AtenololATENOLOLNuCare Pharmaceuticals,Inc.8115a2bc-69aa-60b4-e053-2a91aa0aeae72025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLDirect_Rxee143f2f-be60-bc67-e053-2a95a90ae6e62025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
ATENOLOLATENOLOLdirect rxb3d9f826-7ed7-1e3b-e053-2995a90ae7312025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLNuCare Pharmaceuticals,Inc.9db36b04-f353-55d6-e053-2a95a90ae08f2025-01-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLBryant Ranch Prepack722d6532-20d0-4936-ae9c-b7bb593b960a2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLBryant Ranch Prepackc7a8830a-5eda-4f0e-bf03-61ee8ed6558d2024-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLBryant Ranch Prepack1d6ea66b-30ef-4829-b757-5ea9d412a6662024-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLNuCare Pharmaceuticals,Inc.73671d55-3e10-cb1d-e053-2991aa0ac0382024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197380atenolol 25 MG Oral TabletPSNc7a8830a-5eda-4f0e-bf03-61ee8ed6558d105
197380atenolol 25 MG Oral TabletSCDc7a8830a-5eda-4f0e-bf03-61ee8ed6558d105
197380atenolol 25 MG Oral TabletPSNdb5bd8e2-1314-0f7f-e053-2995a90ae86e7
197380atenolol 25 MG Oral TabletSCDdb5bd8e2-1314-0f7f-e053-2995a90ae86e7
197380atenolol 25 MG Oral TabletPSN741f328d-21a1-3b19-e053-2a91aa0aa3276
197380atenolol 25 MG Oral TabletSCD741f328d-21a1-3b19-e053-2a91aa0aa3276
197379atenolol 100 MG Oral TabletPSN96dd038f-b363-4e24-9c67-82b7c85c3bc45
197380atenolol 25 MG Oral TabletPSN82100fc8-5a5a-4d80-8101-72024ee0abef5
197380atenolol 25 MG Oral TabletPSN96dd038f-b363-4e24-9c67-82b7c85c3bc45
197381atenolol 50 MG Oral TabletPSN96dd038f-b363-4e24-9c67-82b7c85c3bc45
197379atenolol 100 MG Oral TabletSCD96dd038f-b363-4e24-9c67-82b7c85c3bc45
197380atenolol 25 MG Oral TabletSCD96dd038f-b363-4e24-9c67-82b7c85c3bc45
197380atenolol 25 MG Oral TabletSCD82100fc8-5a5a-4d80-8101-72024ee0abef5
197381atenolol 50 MG Oral TabletSCD96dd038f-b363-4e24-9c67-82b7c85c3bc45
197380atenolol 25 MG Oral TabletPSNee143f2f-be60-bc67-e053-2a95a90ae6e64
197380atenolol 25 MG Oral TabletPSNc8cdb347-1767-4595-baff-b50987cd8c3a4
197381atenolol 50 MG Oral TabletPSNc8cdb347-1767-4595-baff-b50987cd8c3a4
197380atenolol 25 MG Oral TabletSCDc8cdb347-1767-4595-baff-b50987cd8c3a4
197380atenolol 25 MG Oral TabletSCDee143f2f-be60-bc67-e053-2a95a90ae6e64
197381atenolol 50 MG Oral TabletSCDc8cdb347-1767-4595-baff-b50987cd8c3a4
197380atenolol 25 MG Oral TabletPSNc3a23869-1e3f-40f0-9726-8337005801133
197380atenolol 25 MG Oral TabletPSN8501f6c1-8157-4189-e053-2a91aa0ac4ef3
197380atenolol 25 MG Oral TabletSCDc3a23869-1e3f-40f0-9726-8337005801133
197380atenolol 25 MG Oral TabletSCD8501f6c1-8157-4189-e053-2a91aa0ac4ef3
197380atenolol 25 MG Oral TabletPSN971926b7-1516-623b-e053-2a95a90a0e4a2
197380atenolol 25 MG Oral TabletSCD971926b7-1516-623b-e053-2a95a90a0e4a2
197380atenolol 25 MG Oral TabletPSN678fc540-33b1-4549-a10d-3bc90c6ecf1b1
197380atenolol 25 MG Oral TabletSCD678fc540-33b1-4549-a10d-3bc90c6ecf1b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64980-437-0164980043701100 TABLET in 1 BOTTLE (64980-437-01) 100 tablet2010-06-100000-00-00NoNoCurrent
64980-437-10649800437101000 TABLET in 1 BOTTLE (64980-437-10) 1000 tablet2010-06-100000-00-00NoNoCurrent