FDA.reportPublic FDA data

NDC 63629-1069-01 - Spironolactone and Hydrochlorothiazide

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
63629-1069
Requested NDC
63629-1069-01
Package NDCs from labels
63629-1069-1, 63629-1069-01
Manufacturer
Bryant Ranch Prepack
Effective date
2026-03-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Spironolactone and Hydrochlorothiazide - Bryant Ranch PrepackBryant Ranch Prepack2026-03-12HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-1069-1Spironolactone and Hydrochlorothiazide500 in 1 BOTTLE, PLASTICTABLET5009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1069SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 1 package rows20240602_905568ae-ce27-4978-90c7-b5c93279ecd1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1069-1EA - Each63629-10696255dfc0-9893-430f-836d-b3fb04dc2dab12020-07-13

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 59 of 86 · 1,713 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spironolactone and HydrochlorothiazideSPIRONOLACTONE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack3c9ceab1-75e9-47b0-a062-33d7d446b88a2024-08-20Warnings, Adverse reactionsExact identifier
application number: ANDA089534
rxcui: 198224
unii: 0J48LPH2TH
unii: 27O7W4T232
Docusate SodiumDOCUSATE SODIUMPadagis Israel Pharmaceuticals Ltdbce3b245-ec47-4e62-9cad-bb12d0812c182024-08-15WarningsExact identifier
unii: F05Q2T2JA0
Docusate SodiumDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.56f7966a-c95e-3ce3-e054-00144ff88e882024-08-14WarningsExact identifier
unii: F05Q2T2JA0
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals, Inc.3e35fb03-9173-6731-e054-00144ff8d46c2024-08-13Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
VermiclearGRANATUM, RHAMNUS PURSHIANA, JUGLANS REGIA, FILIX MAS, ABSINTHIUM, AESCULUS HIPPOCASTANUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, CINA, CUPRUM METALLICUM, IPECACUANHA, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NUX VOMICA, PULSATILLA (VULGARIS), RATANHIA, RHUS TOX, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTHELMIA, TEREBINTHINA, TEUCRIUM MARUMEnergique, Inc.f9df74a8-f225-44ca-91ba-dca4f3f35da02024-08-13WarningsExact identifier
unii: ETJ7Z6XBU4
SpironolactoneSPIRONOLACTONEBryant Ranch Prepack37b9bc61-2757-454a-935b-752d13eb7eb42024-08-12Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
Sool Softener LaxativeDOCUSATE SODIUM, SENNOSIDESEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)7104b955-fadd-4ce7-9342-fb28027fc4a92024-08-12WarningsExact identifier
unii: F05Q2T2JA0
SpironolactoneSPIRONOLACTONEBryant Ranch Prepackb5b129b8-aed9-4d94-a35e-e92647effbdb2024-08-12Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENCS HealthCare of KY, LLC dba Vangard Labs4c1a92c0-b491-4ae9-8bd0-029beb2b13c62024-08-12Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepack204592ba-a68f-452a-9987-1b33b7b6c4d52024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Senna S OrangeDOCUSATE SODIUM SENNOSIDESCare One (Retail Business Services, LLC.)3da76cb2-08c3-475d-9320-69450bbcf8cd2024-08-09WarningsExact identifier
unii: F05Q2T2JA0
Senna PlusDOCUSATE SODIUM, SENNOSIDESAmerisourceBergen (Good Neighbor Pharmacy) 4612268bf0d90-db4b-48f0-bce1-80127922bc822024-08-09WarningsExact identifier
unii: F05Q2T2JA0
Senna SDOCUSATE SODIUM, SENNOSIDESUnited Natural Foods, Inc. dba UNFI3f519d42-72bc-4cc3-a43f-14b94a10eb9a2024-08-09WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener plus LaxativeDOCUSATE SODIUM, SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)ebb35e67-4e83-445e-af6e-ecb43b1d3df62024-08-09WarningsExact identifier
unii: F05Q2T2JA0
Senna SDOCUSATE SODIUM, SENNOSIDESTOP CARE (Topco Associates LLC)3984f4aa-2794-410c-ae9e-ee5bc31c04702024-08-09WarningsExact identifier
unii: F05Q2T2JA0
SpironolactoneSPIRONOLACTONEBryant Ranch Prepack574efac6-b2d9-4053-940c-552f01a69b2e2024-08-08Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SpironolactoneSPIRONOLACTONEBryant Ranch Prepack9d747bf5-31aa-48a5-9c6d-3cf8ce99a8f12024-08-08Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESWinCo Foods, LLC2776d463-753d-4fee-ab5e-210ce36044112024-08-07WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener with laxativeDOCUSATE SODIUM AND SENNOSIDESWinCo Foods, LLC3803830c-187d-4403-9606-db036418386f2024-08-07WarningsExact identifier
unii: F05Q2T2JA0
olmesartan medoxomil / amlodipine besylate / hydrochlorothiazideOLMESARTAN MEDOXOMIL / AMLODIPINE BESYLATE / HYDROCHLOROTHIAZIDEBryant Ranch Prepackbe69f132-8b77-4590-a688-cb37096494662024-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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