FDA.reportPublic FDA data

NDC 63629-9165-01 - PRAVASTATIN SODIUM

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
63629-9165
Requested NDC
63629-9165-01
Package NDCs from labels
63629-9165-1, 63629-9165-2, 63629-9165-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PRAVASTATIN SODIUM - Bryant Ranch PrepackBryant Ranch Prepack2024-08-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9165-1PRAVASTATIN SODIUM30 in 1 BOTTLETABLET30105
63629-9165-2PRAVASTATIN SODIUM60 in 1 BOTTLETABLET60105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9165PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 2 package rows20240816_01beb7e2-ba01-4f2f-8554-4a8ec0941c9f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9165-1EA - Each63629-916535f8ac53-6eea-4e4d-bf9e-e0e96eb3e23912022-03-09
63629-9165-2EA - Each63629-9165297e4f17-936a-4cf5-81e6-49eb44a2f14212022-03-09

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 7 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack03e27551-b3bf-47dd-b3ec-cd9a66ace3c42025-10-30Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
LACRIFRESH HYDRAPFGLYCERIN, POVIDONEAVIZOR, S.A.41bbd23e-0ec8-eb18-e063-6294a90a46d12025-10-27WarningsExact identifier
unii: FZ989GH94E
LACRIFRESH HYDRAMAXPFGLYCERIN, POVIDONEAVIZOR, S.A.41be1604-89b4-7ec3-e063-6294a90a33312025-10-27WarningsExact identifier
unii: FZ989GH94E
Magnesium OxideMAGNESIUM OXIDEKesin Pharma31f417f0-1637-eefa-e063-6294a90a121b2025-10-27WarningsExact identifier
unii: 3A3U0GI71G
Pravastatin sodiumPRAVASTATIN SODIUMNuCare Pharmaceuticals, Inc.3ef390a6-e0a0-331d-e063-6394a90a83d02025-10-27Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
StyePOLYVINYL ALCOHOL AND POVIDONEMedtech Products Inc.60c11d3d-df20-4d1c-b425-49a84fecea302025-10-23WarningsExact identifier
unii: FZ989GH94E
Magnesium OxideMAGNESIUM OXIDEMethod Pharmaceuticals, LLC0af63651-f9d9-43b9-b6f0-4878466a82e62025-10-21WarningsExact identifier
unii: 3A3U0GI71G
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutions45f0fd53-7160-4361-ba0b-3401095441c42025-10-15Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutions635062df-9a84-4ff8-874c-dcee581a55552025-10-15Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
Magnesium OxideMAGNESIUM OXIDEA-S Medication Solutionsc14d2b4d-d6d8-4293-835e-5d893d5b7e6a2025-10-10WarningsExact identifier
unii: 3A3U0GI71G
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions33c141e9-76dc-4e32-9b2a-4621f32ac4bd2025-07-24Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904475
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions72693449-01ee-42b0-9902-5662523245792025-07-24Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904475
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions4015f184-b57e-4d32-9cef-15c6e1cefe242025-05-28Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutionsb7a84cc1-f6e4-40be-9e68-cf7d43bbd6172025-05-28Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
IntimateANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA (HUMAN), GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.066bd402-378b-48aa-9515-188c261a3f4c2025-05-27WarningsExact identifier
unii: 3A3U0GI71G
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack7b7f5c28-78fa-4625-ad69-4291500e033d2025-05-19Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904458
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack51800012-406b-4389-817f-88dd21e338d12025-05-19Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepacka7f75948-2958-44c8-b52f-5e39e80cdd1f2025-05-13Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904458
unii: 3M8608UQ61

Reported adverse events (FAERS/openFDA)#

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