Atenolol

Product NDC
53002-1108
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

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-1108-02025-01-30C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-12025-01-30C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-32025-01-30C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-62025-01-30C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-02023-06-07C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-12023-06-07C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-32023-06-07C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-62023-06-07C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-02023-01-30C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-12023-01-30C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-32023-01-30C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-62023-01-30C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-02020-12-15C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-12020-12-15C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-32020-12-15C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-62020-12-15C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-02020-01-31C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-12020-01-31C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-32020-01-31C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only
53002-1108-62020-01-31C16284748780-19d75b9d0-f96d-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-1108-0Atenolol100 in 1 BOTTLETABLET10011
53002-1108-1Atenolol10 in 1 BOTTLETABLET1011
53002-1108-3Atenolol30 in 1 BOTTLETABLET3011
53002-1108-6Atenolol60 in 1 BOTTLETABLET6011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-1108ATENOLOL TABLET [RPK PHARMACEUTICALS, INC.]11Legacy NDC, 4 package rows20230609_616bf08d-5adf-4d10-9a2e-bcb536b7c2e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSN616bf08d-5adf-4d10-9a2e-bcb536b7c2e011
197380atenolol 25 MG Oral TabletPSN616bf08d-5adf-4d10-9a2e-bcb536b7c2e011
197381atenolol 50 MG Oral TabletPSN616bf08d-5adf-4d10-9a2e-bcb536b7c2e011
197379atenolol 100 MG Oral TabletSCD616bf08d-5adf-4d10-9a2e-bcb536b7c2e011
197380atenolol 25 MG Oral TabletSCD616bf08d-5adf-4d10-9a2e-bcb536b7c2e011
197381atenolol 50 MG Oral TabletSCD616bf08d-5adf-4d10-9a2e-bcb536b7c2e011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-1108-053002110800100 TABLET in 1 BOTTLE (53002-1108-0) 100 tablet2018-10-010000-00-00NoNoCurrent
53002-1108-15300211080110 TABLET in 1 BOTTLE (53002-1108-1) 10 tablet2018-10-010000-00-00NoNoCurrent
53002-1108-35300211080330 TABLET in 1 BOTTLE (53002-1108-3) 30 tablet2018-10-010000-00-00NoNoCurrent
53002-1108-65300211080660 TABLET in 1 BOTTLE (53002-1108-6) 60 tablet2018-10-010000-00-00NoNoCurrent