FDA.reportPublic FDA data

NDC 63629-8539-01 - 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
63629-8539
Requested NDC
63629-8539-01
Package NDCs from labels
63629-8539-1, 63629-8539-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-09-09
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 Prepack2026-09-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8539-1SPIRONOLACTONE1000 in 1 BOTTLE, PLASTICTABLET1000109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8539SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]108Current NDC, Legacy NDC, 1 package rows20240814_753bbc6f-2e50-49c1-b5bf-18f8411a1e8e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8539-1EA - Each63629-8539fabb930b-d50d-45e3-ab87-7a6983eb678812021-07-15

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 8 of 56 · 1,111 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VAXBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), TABEBUIA IMPETIGINOSA, TRIFOLIUM PRATENSE, ARNICA MONTANA, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, LEPTANDRA VIRGINICA, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, MYRRHA, NASTURTIUM AQUATICUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIGONELLA FOENUM-GRAECUM, URTICA DIOICA, HYDRASTIS CANADENSIS, ASTRAGALUS MEMBRANACEUS, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, LYCOPODIUM CLAVATUM, RHUS TOX, SILICEA,BioActive Nutritional, Inc.faa4a678-321a-4982-a5d4-01b713e6862d2026-06-08WarningsExact identifier
unii: ETJ7Z6XBU4
VermexARTEMISIA VULGARIS, CINA, TEUCRIUM MARUM, SPIGELIA ANTHELMIA, FILIX MAS, CALCAREA CARBONICA, GRAPHITES, MERCURIUS CORROSIVUS, SABADILLA, SILICEA, TANACETUM VULGARE, ASCARIS LUMBRICOIDES, TAENIA SOLIUMBioActive Nutritional, Inc.6be5fbcf-bb22-4b20-b65a-d943c516adf92026-06-04WarningsExact identifier
unii: ETJ7Z6XBU4
Senna SSENNOSIDES AND DOCUSATE SODIUMMedline Industries, LP6cd22881-db60-9045-e053-2991aa0ae08a2026-06-04WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMNuCare Pharmaceuticals, Inc.53727f3a-914c-0e2c-e063-6394a90a38862026-06-04WarningsExact identifier
unii: F05Q2T2JA0
BM Silicea Icing SugarSILICEA ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro535ba100-627f-36b4-e063-6394a90a33732026-06-03WarningsExact identifier
unii: ETJ7Z6XBU4
SpironolactoneSPIRONOLACTONECoupler LLC53454970-2c0f-54c3-e063-6294a90aac0a2026-06-02Warnings, Adverse reactionsExact identifier
rxcui: 313096
unii: 27O7W4T232
BM Tooth RemineralizationCALC PHOS, CALC FLUOR, SILICEABM Private Limited5331dc40-2ac8-5fce-e063-6394a90a58752026-06-01WarningsExact identifier
unii: ETJ7Z6XBU4
SpironolactoneSPIRONOLACTONEBryant Ranch Prepack31aeab13-8f71-49f1-b101-8b0abb21b0dc2026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 198222
unii: 27O7W4T232
SpironolactoneSPIRONOLACTONEPD-Rx Pharmaceuticals, Inc.3487305c-25a6-4e82-923c-3e4dd638c9882026-05-28Warnings, Adverse reactionsExact identifier
rxcui: 198223
unii: 27O7W4T232
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
SpironolactoneSPIRONOLACTONEBryant Ranch Prepack473dc80f-11b7-46bf-b0b4-7a271444fca22026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 198223
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack813d199a-9004-4102-8ade-cf877caedafb2026-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA089424
rxcui: 198223
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackbb1423e8-1517-44c5-98e0-99be24ce269b2026-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA089424
rxcui: 198222
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack2d0655d7-fda6-40c6-907c-acaba0e199872026-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA089424
rxcui: 313096
unii: 27O7W4T232
Spironolactone and HydrochlorothiazideSPIRONOLACTONE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackc5258ea3-3aac-48fd-be5a-f8e4a47ca94a2026-05-21Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SpironolactoneSPIRONOLACTONEPD-Rx Pharmaceuticals, Inc.c223a334-7383-429f-b8e3-a21200f169622026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 313096
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1c31c953-05ce-475a-b93f-80aeb12bde952026-05-21Warnings, Adverse reactionsExact identifier
application number: ANDA089424
rxcui: 198222
unii: 27O7W4T232
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacy9983095a-6ef4-4ad7-acc5-e34221fb7c632026-05-20WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMCVS PHARMACY, INC056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a1382026-05-20WarningsExact identifier
unii: F05Q2T2JA0
SpironolactoneSPIRONOLACTONEBryant Ranch Prepack2ed347bc-a9f1-4800-99bc-9af9912ead1f2026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 198222
unii: 27O7W4T232

Reported adverse events (FAERS/openFDA)#

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