FDA.reportPublic FDA data

NDC 63629-1064-05 - 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
63629-1064
Requested NDC
63629-1064-05
Package NDCs from labels
63629-1064-1, 63629-1064-2, 63629-1064-3, 63629-1064-4, 63629-1064-5, 63629-1064-6, 63629-1064-05
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
63629-1064-1SPIRONOLACTONE30 in 1 BOTTLE, PLASTICTABLET3015
63629-1064-2SPIRONOLACTONE60 in 1 BOTTLE, PLASTICTABLET6015
63629-1064-3SPIRONOLACTONE90 in 1 BOTTLE, PLASTICTABLET9015
63629-1064-4SPIRONOLACTONE100 in 1 BOTTLE, PLASTICTABLET10015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1064SPIRONOLACTONE TABLET [BRYANT RANCH PREPACK]15Current NDC, Legacy NDC, 4 package rows20240806_b98b7780-e310-493a-83bd-bb3d93cf8dde.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1064-1EA - Each63629-106459fa66a2-87de-4f5a-914b-8726ffa5b85a12020-07-13
63629-1064-2EA - Each63629-106440efc3fc-bc69-4d2a-aceb-411666364e5112020-07-13
63629-1064-3EA - Each63629-10643d7c249c-b989-4911-bff9-8afb9b0d909512020-07-13

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 58 · 1,147 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
spironolactoneSPIRONOLACTONEREMEDYREPACK INC.8b76a904-6c99-485a-a05f-13a36c5f720c2026-09-15Warnings, Adverse reactionsExact identifier
rxcui: 198222
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack3b60de71-2afa-4922-ba3e-0664c2ae29a02026-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA089424
rxcui: 198223
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackd6138536-cdc1-4459-84ff-9dedc0de11052026-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA089424
rxcui: 313096
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackcaf41e17-0461-4667-9eab-62853b9451312026-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA089424
rxcui: 198223
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepacka6e0bf0e-42d3-41e4-854b-811df3bbaaa92026-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA089424
rxcui: 198223
unii: 27O7W4T232
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1fe93db1-0012-4ff6-a4e6-04e2d7e9f6382026-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA089424
rxcui: 198222
unii: 27O7W4T232
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation4180a35b-cc50-46ae-a100-99bb218c10ff2026-09-09WarningsExact identifier
unii: F05Q2T2JA0
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1b29888c-09f9-4cd5-9b4c-920bd159a7272026-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA089424
rxcui: 313096
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackb98b7780-e310-493a-83bd-bb3d93cf8dde2026-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA089424
ndc (package): 63629-1064-1
ndc (package): 63629-1064-2
ndc (package): 63629-1064-5
ndc (package): 63629-1064-3
ndc (package): 63629-1064-6
ndc (package): 63629-1064-4
ndc (product): 63629-1064
ndc11 (package): 63629106405
rxcui: 313096
spl id: dfe430a5-b0e2-490c-ad67-0722f9bfd22c
spl set id: b98b7780-e310-493a-83bd-bb3d93cf8dde
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack753bbc6f-2e50-49c1-b5bf-18f8411a1e8e2026-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA089424
rxcui: 313096
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack0cc23419-e6d5-4036-8011-dc1d2455e0cb2026-09-09Warnings, Adverse reactionsExact identifier
application number: ANDA089424
rxcui: 198222
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEREMEDYREPACK INC.7c59e03a-b058-4f6e-b104-0836d9b563922026-09-08Warnings, Adverse reactionsExact identifier
application number: ANDA089424
rxcui: 313096
unii: 27O7W4T232
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Kroger Stool Softener Fruit PunchDOCUSATE SODIUMKROGER COMPANYb86f8f3d-594e-466c-854a-b8bff9f7a0b82026-09-02WarningsExact identifier
unii: F05Q2T2JA0
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGPreferred Pharmaceuticals, Inc.b25b8a28-5e00-4a20-9ca3-7ed494fc45402026-09-01WarningsExact identifier
unii: F05Q2T2JA0
SpironolactoneSPIRONOLACTONEPreferred Pharmaceuticals Inc.5e456f3c-f93e-41c6-80c5-a737ed70feda2026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 198223
unii: 27O7W4T232
SpironolactoneSPIRONOLACTONEPreferred Pharmaceuticals Inc.4290b3ec-8993-47d4-bfe3-fcb81d7baed82026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 313096
unii: 27O7W4T232

Reported adverse events (FAERS/openFDA)#

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