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 16 of 86 · 1,713 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackcbc817de-5ea8-4139-9c13-02bac8ff93c32026-03-27Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack59801c48-2af7-4967-ae70-99f865551a7a2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.c2d993ff-b11b-7a62-e053-2995a90a0b002026-03-25Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack1d6712a3-bfb3-4081-b8f6-6057eb4baa272026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
A plus AttentionBARYTA CARBONICA, CALCAREA PHOSPHORICA, SILICEA, GELSEMIUM SEMPERVIRENS, NUX VOMICA, SINAPIS NIGRANaturalCaree77c2661-7ddf-4b09-b2e3-b9db3911011a2026-03-24WarningsExact identifier
unii: ETJ7Z6XBU4
SpironolactoneSPIRONOLACTONEBryant Ranch Prepackce792c44-421d-4274-a333-01e2297ee0a32026-03-20Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
Dynamic BrainARGENTUM NITRICUM, CUPRUM ACETICUM, GINKGO BILOBA, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, THIAMINUM HYDROCHLORICUM, CEREBRUM SUIS, AMBRA GRISEA, PICRICUM ACIDUM, AGNUS CASTUS, ALUMINA, ANACARDIUM ORIENTALE, BARYTA CARBONICA, CICUTA VIROSA, CONIUM MACULATUM, HELLEBORUS NIGER, PLUMBUM METALLICUM, SELENIUM METALLICUM, ZINCUM METALLICUMDeseret Biologicals, Inc.60a1e44b-3f91-41de-82c2-4648fb800dcd2026-03-19WarningsExact identifier
unii: LMI26O6933
Nail Fungus ControlCALENDULA OFFICINALIS FLOWERING TOP AND SILICON DIOXIDEForces of Natureb7239e23-326e-4c1d-a080-55f457f1c4542026-03-19WarningsExact identifier
unii: ETJ7Z6XBU4
Irbesartan and HydrochlorothiazideIRBESARTAN AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack53ce6e4f-db3a-4789-8bef-1e459fa78b792026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Otoflam HPBELLADONNA, CONIUM MACULATUM, DULCAMARA, HEPAR SULPHURIS CALCAREUM, KALI BICHROMICUM, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), SILICEA, CHAMOMILLABioActive Nutritional, Inc.12f1ef62-93f3-45b8-885d-1b82f85a83552026-03-17WarningsExact identifier
unii: ETJ7Z6XBU4
BM BIO18CALC FLUOR, CALC SULF, SILICEA.BM Private Limited4d269a3b-18ba-3ad2-e063-6294a90a1fae2026-03-16WarningsExact identifier
unii: ETJ7Z6XBU4
Stool Softener LaxativeDOCUSATE SODIUMSafeway, Inc.f178b31d-4843-4b91-a0d5-ab5ade835dc22026-03-16WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMSafeway, Inc.12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c2026-03-13WarningsExact identifier
unii: F05Q2T2JA0
LigatoneARNICA MONTANA, BRYONIA, CALCAREA PHOSPHORICA, CAUSTICUM, KALI CARBONICUM, MANGANESE GLUCONATE, MEZEREUM, RHUS TOX, RUTA GRAVEOLENS, SILICEABioActive Nutritional, Inc.3a3bdd55-daec-43b9-a380-54a747fb7d102026-03-13WarningsExact identifier
unii: ETJ7Z6XBU4
Spironolactone and HydrochlorothiazideSPIRONOLACTONE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack905568ae-ce27-4978-90c7-b5c93279ecd12026-03-12Warnings, Adverse reactionsExact identifier
application number: ANDA089534
ndc (package): 63629-1069-1
ndc (product): 63629-1069
ndc11 (package): 63629106901
rxcui: 198224
spl id: 30fc415d-aa70-40fe-81fc-b28c27700191
spl set id: 905568ae-ce27-4978-90c7-b5c93279ecd1
unii: 0J48LPH2TH
unii: 27O7W4T232
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
Stool Softener LaxativeDOCUSATE SODIUMWalgreenscda27a9c-9175-4b07-9c0b-d8d8978829652026-03-12WarningsExact identifier
unii: F05Q2T2JA0
SpironolactoneSPIRONOLACTONEMylan Pharmaceuticals Inc.beaf74db-4159-3b59-ef99-575c3ac99aa12026-03-12Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SpironolactoneSPIRONOLACTONERising Pharma Holdings, Inc.ac487ae2-e15f-4781-bae3-a03058cfcfe42026-03-11Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
HEALIX SENNA-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGBrainstorm Industries LLC4cc5388f-1716-5d19-e063-6394a90a5a252026-03-11WarningsExact identifier
unii: F05Q2T2JA0

Reported adverse events (FAERS/openFDA)#

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