FDA.reportPublic FDA data

NDC 63629-8909-01 - 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
63629-8909
Requested NDC
63629-8909-01
Package NDCs from labels
63629-8909-1, 63629-8909-01
Manufacturer
Bryant Ranch Prepack
Effective date
2025-04-22
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 Prepack2025-04-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8909-1PRAVASTATIN SODIUM1000 in 1 BOTTLETABLET1000105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8909PRAVASTATIN SODIUM TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 1 package rows20250424_0bb2f1e8-9405-4f06-9a33-5ba06765a8e7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8909-1EA - Each63629-89093b1b57c4-29b8-4cce-aca1-6174f79bfb0112022-01-06

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 · 251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
rxcui: 904475
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
ndc (package): 63629-8909-1
ndc (product): 63629-8909
ndc11 (package): 63629890901
rxcui: 904467
spl id: 3366c587-a3d3-cc3f-e063-6394a90a9c37
spl set id: 0bb2f1e8-9405-4f06-9a33-5ba06765a8e7
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

Reported adverse events (FAERS/openFDA)#

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