FDA.reportPublic FDA data

NDC 59762-5011-1 - 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
59762-5011
Requested NDC
59762-5011-1
Package NDCs from labels
59762-5011-2, 59762-5011-1
Manufacturer
Greenstone LLC | Pfizer Inc
Effective date
2020-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
spironolactone - Greenstone LLC | Pfizer IncGreenstone LLC | Pfizer Inc2020-12-31HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-5011-1EA - Each59762-50110d34d549-bd55-4a99-a55a-dbdbd62a610c12012-07-24
59762-5011-2EA - Each59762-50116c94c878-4648-49bf-a291-6f568c874f3612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC]12
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC]12
CALCIUM SULFATE DIHYDRATEINACTIVE INGREDIENT4846Q921YMSPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC]12
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC]12
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC]12
HYPROMELLOSE 2910 (15000 MPA.S)INACTIVE INGREDIENT288VBX44JCSPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC]12
PEPPERMINTINACTIVE INGREDIENTV95R5KMY2BSPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC]12
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC]12
POVIDONESINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC]12
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE TABLET, FILM COATED [GREENSTONE LLC]12

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 1 of 119 · 2,374 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
spironolactoneSPIRONOLACTONEREMEDYREPACK INC.8b76a904-6c99-485a-a05f-13a36c5f720c2026-09-15Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack3b60de71-2afa-4922-ba3e-0664c2ae29a02026-09-09Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackd6138536-cdc1-4459-84ff-9dedc0de11052026-09-09Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackcaf41e17-0461-4667-9eab-62853b9451312026-09-09Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepacka6e0bf0e-42d3-41e4-854b-811df3bbaaa92026-09-09Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1b29888c-09f9-4cd5-9b4c-920bd159a7272026-09-09Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackb98b7780-e310-493a-83bd-bb3d93cf8dde2026-09-09Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack753bbc6f-2e50-49c1-b5bf-18f8411a1e8e2026-09-09Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack0cc23419-e6d5-4036-8011-dc1d2455e0cb2026-09-09Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEREMEDYREPACK INC.7c59e03a-b058-4f6e-b104-0836d9b563922026-09-08Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
SpironolactoneSPIRONOLACTONEPreferred Pharmaceuticals Inc.5e456f3c-f93e-41c6-80c5-a737ed70feda2026-08-31Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SpironolactoneSPIRONOLACTONEPreferred Pharmaceuticals Inc.4290b3ec-8993-47d4-bfe3-fcb81d7baed82026-08-31Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
SPIRONOLACTONESPIRONOLACTONEAtlantic Biologicals Corp.5a203ae4-0ed1-0099-e063-6294a90abc852026-08-28Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEPreferred Pharmaceuticals Inc.3486d831-06b6-4e8f-bd6f-52f7759988f52026-08-27Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232

Reported adverse events (FAERS/openFDA)#

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