FDA.reportPublic FDA data

Atenolol

Product NDC
51138-097
11-digit product format
511380097
Labeler code
51138
Product ID
51138-097_c2cc607c-825f-4ada-bec8-84534c901ec2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Atenolol
Dosage form
TABLET
Route
ORAL
Labeler
Med-Health Pharma, LLC
Application
ANDA078512
Marketing category
ANDA
Marketing start
2011-01-20
Marketing end
0000-00-00
Substance
ATENOLOL
Active strength
50 mg/1
Pharmacologic classes
Adrenergic beta-Antagonists [MoA],beta-Adrenergic Blocker [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
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
51138-097-302019-11-27C16284748780-19855d018-e8ca-cd31-e053-dbdaa90ab51aAtenolol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51138-097-30Atenolol30 in 1 BOTTLETABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51138-097-30EA - Each51138-097e6188ecd-bab5-4d85-8be5-d757e986a19912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [MED-HEALTH PHARMA, LLC]3
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [MED-HEALTH PHARMA, LLC]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATENOLOL TABLET [MED-HEALTH PHARMA, LLC]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKATENOLOL TABLET [MED-HEALTH PHARMA, LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [MED-HEALTH PHARMA, LLC]3
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5ZATENOLOL TABLET [MED-HEALTH PHARMA, LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [MED-HEALTH PHARMA, LLC]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [MED-HEALTH PHARMA, LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51138-097ATENOLOL TABLET [MED-HEALTH PHARMA, LLC]3Legacy NDC, 1 package rows20130208_27522eb0-9e11-45cb-9137-fc50dc78ba80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197379atenolol 100 MG Oral TabletPSN27522eb0-9e11-45cb-9137-fc50dc78ba803
197380atenolol 25 MG Oral TabletPSN27522eb0-9e11-45cb-9137-fc50dc78ba803
197381atenolol 50 MG Oral TabletPSN27522eb0-9e11-45cb-9137-fc50dc78ba803
197379atenolol 100 MG Oral TabletSCD27522eb0-9e11-45cb-9137-fc50dc78ba803
197380atenolol 25 MG Oral TabletSCD27522eb0-9e11-45cb-9137-fc50dc78ba803
197381atenolol 50 MG Oral TabletSCD27522eb0-9e11-45cb-9137-fc50dc78ba803

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
51138-097-305113800973030 in 1 BOTTLEHistorical