FDA.reportPublic FDA data

NDC 63629-8910-01 - 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
63629-8910
Requested NDC
63629-8910-01
Package NDCs from labels
63629-8910-1, 63629-8910-01
Manufacturer
Bryant Ranch Prepack
Effective date
2025-04-23
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 Prepack2025-04-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8910-1PRAVASTATIN SODIUM90 in 1 BOTTLETABLET90105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8910PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20250425_e358f314-9cbe-46a4-9564-6bedc7ef9d59.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8910-1EA - Each63629-8910721484f3-49a3-4701-aa1c-f7c2adaf0d4912022-01-06

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 8 of 13 · 244 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutionsbdf02140-3647-498e-ba0a-f4ca920b4e902025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904475
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.7abc1825-182d-40bc-9f7f-968e197b42462025-04-30Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
Nestabs ONEVITAMIN C, VITAMIN D, VITAMIN E, VITAMIN B6, FOLATE, VITAMIN B12, IRON, ZINC, MAGNESIUM, DHAWomens Choice Pharmaceuticals, LLC9b71b219-91ae-46b2-8fb5-d3d118d738732025-04-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions88e3b5b1-8379-492b-8902-af77f87ad9952025-04-25Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepacke358f314-9cbe-46a4-9564-6bedc7ef9d592025-04-23Warnings, Adverse reactionsExact identifier
application number: ANDA209869
ndc (package): 63629-8910-1
ndc (product): 63629-8910
ndc11 (package): 63629891001
rxcui: 904475
spl id: 3375498b-534d-e8da-e063-6294a90a321b
spl set id: e358f314-9cbe-46a4-9564-6bedc7ef9d59
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack80ddec55-6a18-4b87-8a07-6ae86ad628532025-04-23Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904481
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack2290cad1-55c3-45a0-9d50-dd149678d1912025-04-22Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack0bb2f1e8-9405-4f06-9a33-5ba06765a8e72025-04-22Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904467
unii: 3M8608UQ61
Mag 440MEGNESIUM OXIDEAllegis Pharmaceuticals, LLC2cb19dc0-115b-38b8-e063-6294a90a4aea2025-04-17WarningsExact identifier
unii: 3A3U0GI71G
Magnesium OxideMAGNESIUM OXIDEBelleview Biosciences31bc45c7-ba92-bad0-e063-6394a90a9af82025-04-01WarningsExact identifier
unii: 3A3U0GI71G
Strovite One CapletsVITAMIN A, CALCIUM PANTOTHENATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL SUCCINATE, D-, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, BIOTIN, CYANOCOBALAMIN, SELENIUM, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC SULFATE, MANGANESE, CHROMIUM, .ALPHA.-LIPOIC ACID, AND LUTEINExeltis USA, Inc.b9b71fa4-89c7-4f5b-8174-950649434ba52025-03-20Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Vitafol Fe PlusDOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, BETA CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, IRON, ZINC OXIDE, CUPRIC OXIDE, POTASSIUM IODIDE, MAGNESIUM OXIDE, FOLIC ACID, AND LEVOMEFOLATE CALCIUMExeltis USA, Inc.3927b074-d72a-4d8c-9f7e-15c42a8309452025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAphena Pharma Solutions - Tennessee, LLC308db0cc-0deb-99b6-e063-6394a90a9b742025-03-17Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904475
unii: 3M8608UQ61
Vitafol UltraDOCONEXENT, NIACINAMIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, CHOLECALCIFEROL, .BETA.-CAROTENE, ASCORBIC ACID, THIAMINE MONONITRATE, RIBOFLAVIN, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, IRON, ZINC OXIDE, CUPRIC OXIDE, POTASSIUM IODIDE, MAGNESIUM OXIDE, FOLIC ACID, AND LEVOMEFOLATE CALCIUMExeltis USA, Inc.40fa2c3a-f41f-434c-91de-5150a18d3e4b2025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Pravastatin sodiumPRAVASTATIN SODIUMAurobindo Pharma Limitedc21d4797-d252-4073-891f-330484c5f6432025-02-18Warnings, Adverse reactionsExact identifier
rxcui: 904481
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMAurobindo Pharma Limitedcf6f7031-33b9-40d3-bc87-32f1b6af98f22025-02-18Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAphena Pharma Solutions - Tennessee, LLC2e5c8a1c-b36f-d124-e063-6394a90a6fb52025-02-17Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904481
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAphena Pharma Solutions - Tennessee, LLC2e5cfae8-20b8-1fea-e063-6394a90a4e172025-02-17Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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