Spironolactone

Product NDC
63739-545
11-digit product format
637390545
Labeler code
63739
Product ID
63739-545_cf80cf51-576c-3b92-e053-2995a90a5f60
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA091426
Marketing category
ANDA
Marketing start
2011-06-01
Marketing end
0000-00-00
Substance
SPIRONOLACTONE
Active strength
50 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC],Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-545-102020-07-22C16284748780-1ab0e2407-2929-f274-e053-dbdaa90a647101deb112-edf1-4ed6-bc04-672d02ce66ab

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-545-10EA - Each63739-54579673e03-5386-4e8c-9ec7-45a6618911ad12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BSPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
POLYETHYLENE GLYCOL 3000INACTIVE INGREDIENTSA1B764746SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BSPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TALCINACTIVE INGREDIENT7SEV7J4R1USPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-545SPIRONOLACTONE TABLET [MCKESSON CORPORATION DBA SKY PACKAGING]15Legacy NDC20250115_01deb112-edf1-4ed6-bc04-672d02ce66ab.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-545-106373905451010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-545-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2011-06-010000-00-00NoNoCurrent