FDA.reportPublic FDA data

Atenolol

Product NDC
43353-833
11-digit product format
433530833
Labeler code
43353
Product ID
43353-833_dac66f7f-c5e7-4781-a1d1-540604e87d76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
2019-12-31
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
43353-833-302020-01-31C16284748780-19d75b9cf-f7c7-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753
43353-833-452020-01-31C16284748780-19d75b9cf-f7c7-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753
43353-833-602020-01-31C16284748780-19d75b9cf-f7c7-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753
43353-833-802020-01-31C16284748780-19d75b9cf-f7c7-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753
43353-833-922020-01-31C16284748780-19d75b9cf-f7c7-f424-e053-dadaa90a57ceATENOLOL TABLETS USP 0787 0752 0753

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-833-30Atenolol30 in 1 BOTTLE, PLASTICTABLET301
43353-833-45Atenolol45 in 1 BOTTLE, PLASTICTABLET451
43353-833-60Atenolol90 in 1 BOTTLE, PLASTICTABLET901
43353-833-80Atenolol180 in 1 BOTTLE, PLASTICTABLET1801
43353-833-92Atenolol270 in 1 BOTTLE, PLASTICTABLET2701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-833-30EA - Each43353-83352d55d72-89e1-4e74-865b-1392dab3e9de12014-06-03
43353-833-45EA - Each43353-83384285309-969d-4b4e-bca4-db15e02a8dfc12014-06-03
43353-833-60EA - Each43353-8336290f125-196b-482e-8af8-8884a4ae870912014-06-03
43353-833-80EA - Each43353-8339687c1b8-9ca7-44b6-9ca2-a7d38647d70e12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
POVIDONE K30INACTIVE INGREDIENTU725QWY32XATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-833ATENOLOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 5 package rows20140516_c53a6028-840e-4e24-9c4e-d487782e0a20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197380atenolol 25 MG Oral TabletPSNc53a6028-840e-4e24-9c4e-d487782e0a201
197380atenolol 25 MG Oral TabletSCDc53a6028-840e-4e24-9c4e-d487782e0a201

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-833-304335308333030 in 1 BOTTLE, PLASTICHistorical
43353-833-454335308334545 in 1 BOTTLE, PLASTICHistorical
43353-833-604335308336090 in 1 BOTTLE, PLASTICHistorical
43353-833-8043353083380180 in 1 BOTTLE, PLASTICHistorical
43353-833-9243353083392270 in 1 BOTTLE, PLASTICHistorical