FDA.reportPublic FDA data

Spironolactone

Product NDC
51079-103
11-digit product format
510790103
Labeler code
51079
Product ID
51079-103_3a873ff3-7c53-afd9-e063-6294a90a155f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA040424
Marketing category
ANDA
Marketing start
1996-12-23
Substance
SPIRONOLACTONE
Active strength
25 mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Spironolactone
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SPIRONOLACTONE25 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
51079-103-01Spironolactone1 in 1 BLISTER PACKTABLET, FILM COATED111
51079-103-20Spironolactone100 in 1 CARTONTABLET, FILM COATED10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-103-01EA - Each51079-103d1c2c130-9a00-4258-bec5-a97cf812e9b012013-02-13
51079-103-17EA - Each51079-1030986b7b2-9007-42ef-bac6-46a89f999f2912013-02-13
51079-103-19EA - Each51079-1032a3e7676-1b68-4a77-8778-73dc57cf099012013-02-13
51079-103-20EA - Each51079-10301c8f7ca-a506-4b9d-936e-7c837751dd5912013-02-13
51079-103-63EA - Each51079-103e72a423c-edb2-45d3-9c01-2c3b6bdb1c3012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
AMMONIUM LAURETH-5 SULFATEINACTIVE INGREDIENT43ZIH89I48SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
CALCIUM SULFATE DIHYDRATEINACTIVE INGREDIENT4846Q921YMSPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
POVIDONESINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET, FILM COATED [CARDINAL HEALTH]10
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
51079-103SPIRONOLACTONE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.]10Current NDC, Legacy NDC, 2 package rows20231228_7e1a8152-941a-4aa4-bcb0-83c04905678f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313096spironolactone 25 MG Oral TabletPSN48115c9e-c82f-438d-b178-dce1b73687db21
313096spironolactone 25 MG Oral TabletSCD48115c9e-c82f-438d-b178-dce1b73687db21
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-103-01510790103011 in 1 BLISTER PACKHistorical
51079-103-2051079010320100 BLISTER PACK in 1 CARTON (51079-103-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-103-01) 100 blister pack1996-12-230000-00-00NoNoCurrent