FDA.reportPublic FDA data

NDC 63629-9162-01 - 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
63629-9162
Requested NDC
63629-9162-01
Package NDCs from labels
63629-9162-1, 63629-9162-2, 63629-9162-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-08-30
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 Prepack2024-08-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9162-1PRAVASTATIN SODIUM30 in 1 BOTTLETABLET30104
63629-9162-2PRAVASTATIN SODIUM60 in 1 BOTTLETABLET60104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9162PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 2 package rows20240901_6bb60d07-0787-4d5f-8a8c-1224d5b02b2b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9162-1EA - Each63629-9162457ee6db-9af1-4915-afea-a2a00c55aa0812022-03-09
63629-9162-2EA - Each63629-916272e3389f-34b9-4e2b-bbf9-1d4a2fddc2a812022-03-09

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 6 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Artificial TearsPOLYVINYL ALCOHOL, POVIDONEWalmart, Inc.ead9f271-0f15-1fff-e053-2a95a90a93ac2025-12-30WarningsExact identifier
unii: FZ989GH94E
Eye Love Heyedrate Long Lasting HydrationGLYCERIN, POVIDONEPhysician Recommended Neutraceuticals, L.P.f321dea1-3251-eaa8-e053-2995a90aaf952025-12-30WarningsExact identifier
unii: FZ989GH94E
Quality Choice Moisturizing Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLChain Drug Marketing Association, Inc.1fb81759-5931-59c8-e063-6294a90a22772025-12-30WarningsExact identifier
unii: FZ989GH94E
Pravastatin sodiumPRAVASTATIN SODIUMNorthwind Health Company, LLC47207487-0c6d-8da3-e063-6294a90a8aee2025-12-29Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904475
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMNorthwind Health Company, LLC471b4dac-057d-740c-e063-6294a90af9e92025-12-19Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
Dem ZeroPHOSPHATIDYLSERINE, MAGNESIUM OXIDENPG Bio Pharmaceuticals Co.,Ltd.411f1a0f-ed02-cc78-e063-6394a90a0aec2025-12-18WarningsExact identifier
unii: 3A3U0GI71G
Alzh LPHOSPHATIDYLSERINE, MAGNESIUM OXIDENPG Bio Pharmaceuticals Co.,Ltd.41056de0-aaa2-01bb-e063-6394a90af7b82025-12-18WarningsExact identifier
unii: 3A3U0GI71G
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutionsfd76794d-de33-4886-875c-fa05b2639f842025-12-10Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCoupler LLC4573c42b-6d4a-e001-e063-6294a90acea12025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.f92e12bc-40c3-4afa-9190-2f4de11ec6b32025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack12943de2-c7e9-4651-89f3-fc6cb52766762025-11-17Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack97123f09-b5ad-45c2-8bb7-f50566b56b082025-11-17Warnings, Adverse reactionsExact identifier
rxcui: 904481
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack2ba7af14-9c87-4eb0-84c9-7e895cd75fae2025-11-14Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.6c011348-a236-47d3-bbef-3e0b956dd0802025-11-14Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
Magnesium OxideMAGNESIUM OXIDEMarlex Pharmaceuticals Inc0bb322a5-fb92-14de-e063-6294a90a4c1b2025-11-14WarningsExact identifier
unii: 3A3U0GI71G
magnesium oxideMAGNESIUM OXIDEMarlex Pharmaceuticals Inc.dc57893c-068a-37d8-e053-2a95a90aa0542025-11-14WarningsExact identifier
unii: 3A3U0GI71G
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepack4ed7a4d1-1183-4d95-8311-6d3e58feafa82025-11-10Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904458
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepack91c5b5c8-3379-4b84-aff7-ef6cfc65fe9f2025-11-10Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackabcfc343-7ac9-4fce-b368-fd05cf14b0e22025-11-04Warnings, Adverse reactionsExact identifier
rxcui: 904481
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.e6a3d99c-c9cc-49d9-b0f9-503770307b702025-10-31Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61

Reported adverse events (FAERS/openFDA)#

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