Spironolactone

Product NDC
68151-2776
11-digit product format
681512776
Labeler code
68151
Product ID
68151-2776_104fd1b1-ea21-4a75-a48e-6ae9c29f2e61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA040353
Marketing category
ANDA
Marketing start
2007-01-03
Marketing end
0000-00-00
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d335cba1-5b36-51c8-120a-594ec9d05330Product name520251114
25f5e2cf-3572-477b-994c-aa692751e5a8Product name220250616
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-2776-12020-01-31C16284748780-19d75b9d0-fe14-f424-e053-dadaa90a57ceSPIRONOLACTONE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-2776-1Spironolactone1 in 1 BOTTLETABLET, FILM COATED13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
DEXTROSEINACTIVE INGREDIENTIY9XDZ35W2SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DSPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BSPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQSPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-2776SPIRONOLACTONE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20150806_857d5b98-d499-4a0d-9b40-2724bb45dd8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN857d5b98-d499-4a0d-9b40-2724bb45dd8c3
313096spironolactone 25 MG Oral TabletSCD857d5b98-d499-4a0d-9b40-2724bb45dd8c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-2776-1681512776011 in 1 BOTTLEHistorical