FDA.reportPublic FDA data

Atenolol

Product NDC
33261-517
11-digit product format
332610517
Labeler code
33261
Product ID
33261-517_e821edd9-cd2c-4f50-92a2-ab13a5823e86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077877
Marketing category
ANDA
Marketing start
2007-12-04
Marketing end
0000-00-00
Substance
ATENOLOL
Active strength
100 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
33261-517-302020-01-31C16284748780-19d75b9cf-d7ff-f424-e053-dadaa90a57ceAtenolol Tablets, USP
33261-517-602020-01-31C16284748780-19d75b9cf-d7ff-f424-e053-dadaa90a57ceAtenolol Tablets, USP
33261-517-902020-01-31C16284748780-19d75b9cf-d7ff-f424-e053-dadaa90a57ceAtenolol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-517-30Atenolol30 in 1 BOTTLETABLET303
33261-517-60Atenolol60 in 1 BOTTLETABLET603
33261-517-90Atenolol90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-517-30EA - Each33261-5177d352306-2815-4ec1-ba15-4fc9362c5ee612015-10-02
33261-517-60EA - Each33261-51727ad7d1c-b708-41e4-857e-b46b82b94fe012015-10-02
33261-517-90EA - Each33261-51701bfdef1-84ea-4700-a247-5402c02ba7d212015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [AIDAREX PHARMACEUTICALS LLC]3
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [AIDAREX PHARMACEUTICALS LLC]3
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAATENOLOL TABLET [AIDAREX PHARMACEUTICALS LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [AIDAREX PHARMACEUTICALS LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [AIDAREX PHARMACEUTICALS LLC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JATENOLOL TABLET [AIDAREX PHARMACEUTICALS LLC]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [AIDAREX PHARMACEUTICALS LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJATENOLOL TABLET [AIDAREX PHARMACEUTICALS LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-517ATENOLOL TABLET [AIDAREX PHARMACEUTICALS LLC]3Legacy NDC, 3 package rows20120913_3ee0fa02-8fcc-4b56-98a7-1f636ae0bd74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSN3ee0fa02-8fcc-4b56-98a7-1f636ae0bd743
197380atenolol 25 MG Oral TabletPSN3ee0fa02-8fcc-4b56-98a7-1f636ae0bd743
197381atenolol 50 MG Oral TabletPSN3ee0fa02-8fcc-4b56-98a7-1f636ae0bd743
197379atenolol 100 MG Oral TabletSCD3ee0fa02-8fcc-4b56-98a7-1f636ae0bd743
197380atenolol 25 MG Oral TabletSCD3ee0fa02-8fcc-4b56-98a7-1f636ae0bd743
197381atenolol 50 MG Oral TabletSCD3ee0fa02-8fcc-4b56-98a7-1f636ae0bd743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-517-303326105173030 in 1 BOTTLEHistorical
33261-517-603326105176060 in 1 BOTTLEHistorical
33261-517-903326105179090 in 1 BOTTLEHistorical