FDA.reportPublic FDA data

Spironolactone

Product NDC
0378-0243
11-digit product format
003780243
Labeler code
0378
Product ID
0378-0243_b78b6da0-ce99-4c8f-bf36-c4e19b34dfd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA040424
Marketing category
ANDA
Marketing start
2002-01-22
Substance
SPIRONOLACTONE
Active strength
50 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Spironolactone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPIRONOLACTONE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii27O7W4T232
Rxcui198222, 198223, 313096

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-0243-01Spironolactone100 in 1 BOTTLE, PLASTICTABLET, FILM COATED10020
0378-0243-05Spironolactone500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0243-01EA - Each0378-0243fe1eb3ae-9167-4b2f-a158-5435f09ca0bf12012-07-24
0378-0243-05EA - Each0378-024391884336-dc5d-4fba-84fe-694a122bee3b12012-07-24
0378-0243-93EA - Each0378-0243545a6857-fecb-424a-a4f3-dfe4f5f6235c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
CALCIUM SULFATE DIHYDRATEINACTIVE INGREDIENT4846Q921YMSPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
POVIDONESINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
CALCIUM SULFATE DIHYDRATEINACTIVE INGREDIENT4846Q921YMSPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0243SPIRONOLACTONE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]18Current NDC, Legacy NDC, 2 package rows20230308_beaf74db-4159-3b59-ef99-575c3ac99aa1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198222spironolactone 100 MG Oral TabletPSNbeaf74db-4159-3b59-ef99-575c3ac99aa120
313096spironolactone 25 MG Oral TabletPSNbeaf74db-4159-3b59-ef99-575c3ac99aa120
198223spironolactone 50 MG Oral TabletPSNbeaf74db-4159-3b59-ef99-575c3ac99aa120
198222spironolactone 100 MG Oral TabletSCDbeaf74db-4159-3b59-ef99-575c3ac99aa120
313096spironolactone 25 MG Oral TabletSCDbeaf74db-4159-3b59-ef99-575c3ac99aa120
198223spironolactone 50 MG Oral TabletSCDbeaf74db-4159-3b59-ef99-575c3ac99aa120
198222spironolactone 100 MG Oral TabletPSN7e1a8152-941a-4aa4-bcb0-83c04905678f11
313096spironolactone 25 MG Oral TabletPSN7e1a8152-941a-4aa4-bcb0-83c04905678f11
198223spironolactone 50 MG Oral TabletPSN7e1a8152-941a-4aa4-bcb0-83c04905678f11
198222spironolactone 100 MG Oral TabletSCD7e1a8152-941a-4aa4-bcb0-83c04905678f11
313096spironolactone 25 MG Oral TabletSCD7e1a8152-941a-4aa4-bcb0-83c04905678f11
198223spironolactone 50 MG Oral TabletSCD7e1a8152-941a-4aa4-bcb0-83c04905678f11
198222spironolactone 100 MG Oral TabletPSN7057c090-67c2-414c-9077-bed18ad4b0b32
313096spironolactone 25 MG Oral TabletPSN7057c090-67c2-414c-9077-bed18ad4b0b32
198223spironolactone 50 MG Oral TabletPSN7057c090-67c2-414c-9077-bed18ad4b0b32
198222spironolactone 100 MG Oral TabletSCD7057c090-67c2-414c-9077-bed18ad4b0b32
313096spironolactone 25 MG Oral TabletSCD7057c090-67c2-414c-9077-bed18ad4b0b32
198223spironolactone 50 MG Oral TabletSCD7057c090-67c2-414c-9077-bed18ad4b0b32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0378-0243-0100378024301100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0243-01) 2002-01-220000-00-00NoNoCurrent
0378-0243-0500378024305500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0243-05) 2009-06-260000-00-00NoNoCurrent