Spironolactone

Product NDC
55154-1495
11-digit product format
551541495
Labeler code
55154
Product ID
55154-1495_05cceb7a-5309-4d87-b80c-640e41699907
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Spironolactone
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA091426
Marketing category
ANDA
Marketing start
2011-06-01
Marketing end
0000-00-00
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET [CARDINAL HEALTH]3
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET [CARDINAL HEALTH]3
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SPIRONOLACTONE TABLET [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET [CARDINAL HEALTH]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SPIRONOLACTONE TABLET [CARDINAL HEALTH]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET [CARDINAL HEALTH]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET [CARDINAL HEALTH]3
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BSPIRONOLACTONE TABLET [CARDINAL HEALTH]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET [CARDINAL HEALTH]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BSPIRONOLACTONE TABLET [CARDINAL HEALTH]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET [CARDINAL HEALTH]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET [CARDINAL HEALTH]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET [CARDINAL HEALTH]3
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET [CARDINAL HEALTH]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-1495SPIRONOLACTONE TABLET [CARDINAL HEALTH 107, LLC]13Legacy NDC20240214_2e8c338a-e2aa-4e09-b5e0-ce7f7dd7f1f7.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-1495-05515414950010 BLISTER PACK in 1 BAG (55154-1495-0) > 1 TABLET in 1 BLISTER PACK10 blister pack2011-06-010000-00-00NoNoCurrent