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 32 of 86 · 1,713 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEADACHE HPSILVER NITRATE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, GELSEMIUM SEMPERVIRENS ROOT, NITROGLYCERIN, LACHESIS MUTA VENOM, LYCOPODIUM CLAVATUM SPORE, MELILOTUS OFFICINALIS TOP, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, SPIGELIA ANTHELMIANatural Creations, Inc.c38b83f0-3918-4ef6-8dfd-48fe438e584a2025-12-12WarningsExact identifier
unii: ETJ7Z6XBU4
Cell WellCALCIUM CARBONICA,CALCIUM FLUORATUM,CALCIUM PHOSPHORICUM,CALCIUM SULPHURICUM,FERRUM PHOSPHORICUM,KALIUM MURIATICUM,KALIUM PHOSPHORICUM,KALIUM SULPHURICUM,MAGNESIUM CARBONICA,MAGNESIUM PHOSPHORICUM,NATRUM MURIATICUM,NATRUM PHOSPHORICUM,NATRUM SULPHURICUM,SILICEAJoyWell Co LLC592c1f48-21c8-4ff5-8818-046662c9effe2025-12-11WarningsExact identifier
unii: ETJ7Z6XBU4
GeriCare Docusate Sodium LiquidDOCUSATE SODIUMGERI-CARE PHARMACEUTICALS, CORPd599ff49-c9a4-401a-a50b-63d89749bbed2025-12-11WarningsExact identifier
unii: F05Q2T2JA0
DIZZINESS HPOYSTER SHELL CALCIUM CARBONATE CRUDE, CHENOPODIUM AMBROSIOIDES, ANAMIRTA COCCULUS SEED, CONIUM MACULATUM FLOWERING TOP, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PULSATILLA VULGARIS, SILICON DIOXIDENatural Creations, Inc.9701096b-5efa-4acd-9227-339ecedfd6722025-12-10WarningsExact identifier
unii: ETJ7Z6XBU4
HydrochlorothiazideHYDROCHLOROTHIAZIDEChartwell RX, LLC4e43dd27-3f4b-4205-a26e-6ecaa82813472025-12-10Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
TRIAMTERENE AND HYDROCHLOROTHIAZIDETRIAMTERENE AND HYDROCHLOROTHIAZIDEChartwell RX, LLC261dd83f-8048-488f-8b71-c4abd96927202025-12-10Adverse reactionsExact identifier
unii: 0J48LPH2TH
Docusate SodiumDOCUSATE SODIUMMajor Pharmaceuticals3e8321cf-7eda-d70c-e063-6394a90a35a52025-12-10WarningsExact identifier
unii: F05Q2T2JA0
Olmesartan Medoxomil and HydrochlorothiazideOLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDELifestar Pharma LLC9771066e-c05d-6a93-e053-2995a90a7e872025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Stool SoftenerDOCUSATE SODIUMHEB2f103a88-4cab-d4b9-e063-6394a90ac7fc2025-12-09WarningsExact identifier
unii: F05Q2T2JA0
Spironolactone and HydrochlorothiazideSPIRONOLACTONE AND HYDROCHLOROTHIAZIDESun Pharmaceutical Industries, Inc.d7fa3c79-9f26-415b-8039-eb2acabcf66b2025-12-09Warnings, Adverse reactionsExact identifier
application number: ANDA089534
ndc (product): 53489-144
rxcui: 198224
spl id: b1902b0c-42e6-4e08-bb4a-959280f33579
spl set id: d7fa3c79-9f26-415b-8039-eb2acabcf66b
unii: 0J48LPH2TH
unii: 27O7W4T232
spironolactoneSPIRONOLACTONEZydus Lifesciences Limited963af399-feb7-49d2-a59c-c19edad9c6822025-12-08Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
Stool SoftenerDOCUSATE SODIUMHEB2efb4c5a-2c5e-acf6-e063-6394a90a934e2025-12-08WarningsExact identifier
unii: F05Q2T2JA0
Stool SoftenerDOCUSATE SODIUMHEB2f10041a-8c88-09a5-e063-6294a90a07cc2025-12-08WarningsExact identifier
unii: F05Q2T2JA0
Secale QuartzSECALE QUARTZUriel Pharmacy Inc.1e9f55d7-22d5-4412-ac35-b4400bdf29a02025-12-08WarningsExact identifier
unii: ETJ7Z6XBU4
spironolactoneSPIRONOLACTONEZydus Pharmaceuticals (USA) Inc.99bbc053-0e41-4b4d-979a-db610908f2de2025-12-08Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
Sodium phenylacetate and Sodium benzoateSODIUM PHENYLACETATE AND SODIUM BENZOATENavinta LLCd20768fe-4516-483a-a082-ff1df9ad1d992025-12-06Warnings, Adverse reactionsExact identifier
unii: OJ245FE5EU
hydrochlorothiazideHYDROCHLOROTHIAZIDEQPharma Inc578f74ea-53d1-4c44-b872-66033292abe02025-12-05Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Lisinopril and HydrochlorothiazideLISINOPRIL AND HYDROCHLOROTHIAZIDEQPharma Incff7b2d81-9006-465d-9095-1bd8696a12a62025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
HydrochlorothiazideHYDROCHLOROTHIAZIDEQPharma, Inc.5bacc909-6b02-4815-85ef-55fd25b1b1f72025-12-05Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH
Losartan Potassium and HydrochlorothiazideLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDEJubilant Cadista Pharmaceuticals Inc.e0b74a86-3d36-1af0-e538-41b45b8d2cc32025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 0J48LPH2TH

Reported adverse events (FAERS/openFDA)#

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