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 60 of 86 · 1,713 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPIRONOLACTONESPIRONOLACTONENCS HealthCare of KY, LLC dba Vangard Labse34fc3ca-1272-446b-8dc2-25b62add01c32024-08-05Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
Spironolactone and HydrochlorothiazideSPIRONOLACTONE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackcc58a6a5-5ccd-451c-837c-781d0a8da5cf2024-08-05Warnings, Adverse reactionsExact identifier
application number: ANDA089534
rxcui: 198224
unii: 0J48LPH2TH
unii: 27O7W4T232
Stool Softener LaxativeDOCUSATE SODIUMProficient Rx LPccfa095c-77f0-41ff-84f8-e02d983c7c742024-08-01WarningsExact identifier
unii: F05Q2T2JA0
Mind Detox and DrainageALUMINA, BARYTA CARBONICA, CARBONEUM SULPHURATUM, CEREBRUM SUIS, CONIUM MACULATUM, HELLEBORUS NIGER, LECITHIN, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, MERCURIUS SOLUBILIS, NAJA TRIPUDIANS, PICRICUM ACIDUM, PLATINUM METALLICUM, SILICEA, STRAMONIUM, SULPHURICUM ACIDUM, ZINCUM PHOSPHORATUMDeseret Biologicals, Inc.1ac1e955-a374-4cac-b997-51c6aef8d35d2024-08-01WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4
SpironolactoneSPIRONOLACTONEJubilant Cadista Pharmacuticals Inc.c1c5fdab-3ff7-414b-8e25-beed8311b8ad2024-08-01Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
Stool SoftenerDOCUSATE SODIUM SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)d4128fbd-32ba-4d2e-ae1a-cbe438f5b39b2024-07-31WarningsExact identifier
unii: F05Q2T2JA0
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsb78ad43f-f132-4f03-8c85-2cf9b3ab555b2024-07-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESWalgreensdb528659-768a-46e0-a340-9fbcdb25ea5e2024-07-25WarningsExact identifier
unii: F05Q2T2JA0
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.1e02787f-ccb5-abc2-e063-6294a90af7c32024-07-24Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESGOOD SENSE17cdef7b-71bf-b4a6-e063-6294a90a5b742024-07-22WarningsExact identifier
unii: F05Q2T2JA0
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals, Inc.4af326db-bf2d-5310-e054-00144ff88e882024-07-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.7cc69c16-0dcc-874d-e053-2991aa0a99192024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSNuCare Pharmaceuticals,Inc.af74c331-7402-408c-e053-2a95a90a10432024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSNuCare Pharmaceuticals,Inc.b2e8b3bb-0ab5-ffd7-e053-2995a90aa2b62024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETSNuCare Pharmaceuticals,Inc.b4c9abf7-a2c6-7042-e053-2a95a90a76532024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and hydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENuCarePharmaceuticals, Inc.4fbf31a1-037b-31a2-e054-00144ff88e882024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
SpironolactoneSPIRONOLACTONEJubilant Cadista Pharmacuticals Inc.a7510768-8a52-4230-6aa0-b0d92d82588f2024-07-17Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.7c214ebf-e0ed-6538-e053-2991aa0a80792024-07-16Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals, Inc.4925a3ad-63bd-108a-e054-00144ff8d46c2024-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
SpironolactoneSPIRONOLACTONENuCare Pharmaceuticals, Inc.540ee876-78fb-1792-e054-00144ff88e882024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232

Reported adverse events (FAERS/openFDA)#

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