NDC 63629-5341-01 - SPIRONOLACTONE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63629-5341
Requested NDC
63629-5341-01
Package NDCs from labels
63629-5341-1, 63629-5341-2, 63629-5341-3, 63629-5341-4, 63629-5341-5, 63629-5341-6, 63629-5341-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-04-03
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SPIRONOLACTONE - Bryant Ranch PrepackBryant Ranch Prepack2026-04-03HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-5341-1SPIRONOLACTONE30 in 1 BOTTLETABLET, FILM COATED301015
63629-5341-2SPIRONOLACTONE60 in 1 BOTTLETABLET, FILM COATED601015
63629-5341-3SPIRONOLACTONE90 in 1 BOTTLETABLET, FILM COATED901015
63629-5341-4SPIRONOLACTONE100 in 1 BOTTLETABLET, FILM COATED1001015
63629-5341-5SPIRONOLACTONE14 in 1 BOTTLETABLET, FILM COATED141015
63629-5341-6SPIRONOLACTONE10 in 1 BOTTLETABLET, FILM COATED101015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5341SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1014Current NDC, Legacy NDC, 6 package rows20231128_cae68fd6-5161-4650-bcde-6db98cbe6c8b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKSPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
DOCUSATE SODIUMINACTIVE INGREDIENTF05Q2T2JA0SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IESPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
TRIACETININACTIVE INGREDIENTXHX3C3X673SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]1000

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 6 of 156 · 3,114 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPIRONOLACTONESPIRONOLACTONERedpharm Drug57d1c333-c229-54aa-e063-6394a90a84ce2026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 198223
unii: 27O7W4T232
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMCardinal Health 107, LLCb5e4b14d-bf11-4309-bf6d-65ee9d877a242026-07-28WarningsExact identifier
unii: F05Q2T2JA0
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackdeca083b-5c72-40fa-9021-b74028426a5a2026-07-20WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCfc5e82b6-e25c-4686-9781-2205819685f52026-07-20WarningsExact identifier
unii: F05Q2T2JA0
SpironolactoneSPIRONOLACTONEPD-Rx Pharmaceuticals, Inc.73564b3d-8ede-4008-b75c-1277153b5bb62026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 313096
unii: 27O7W4T232
SpironolactoneSPIRONOLACTONEPD-Rx Pharmaceuticals, Inc.8a66d90e-5450-4716-8c01-e7dc1967d00d2026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 198223
unii: 27O7W4T232
SpironolactoneSPIRONOLACTONEPD-Rx Pharmaceuticals, Inc.8cbe2215-744c-438a-b3d6-b7d6ae7692312026-07-17Warnings, Adverse reactionsExact identifier
rxcui: 198222
unii: 27O7W4T232
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
stool softenerDOCUSATE SODIUMAmazon.com Services LLC4f83953e-3779-43b7-a5c6-7442a0675d9b2026-07-16WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Extra StrengthDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)183576bd-c252-471b-8797-32cac5b0329c2026-07-16WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMWalgreens3f9d54d9-a9d5-40ff-a8a2-431997b589992026-07-16WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMWalgreens7174021b-bdc0-4fd3-90e7-3904980033c42026-07-16WarningsExact identifier
unii: F05Q2T2JA0
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackbe4aa233-1555-4972-858e-46343a7105582026-07-16Warnings, Adverse reactionsExact identifier
application number: ANDA089424
rxcui: 198223
unii: 27O7W4T232

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.