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 4 of 13 · 251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ConnectionANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.214eb19a-e7a2-421c-9f34-724ce430185c2026-04-10WarningsExact identifier
unii: 3A3U0GI71G
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutionsb7f8c679-a602-4268-81b6-962a136a4e432026-04-02Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions8df47d82-5b09-414d-99f1-7ac4c77f7c012026-04-02Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
Magnesium OxideMAGNESIUM OXIDEBryant Ranch Prepackf98cac25-63f2-478e-b785-20cba1c565652026-03-27WarningsExact identifier
unii: 3A3U0GI71G
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackf4b330ce-dfb0-4e4e-9f37-482458820c662026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNCS HealthCare of KY, LLC dba Vangard Labs64ccb4b5-b77e-4b23-8c74-4685287edb4b2026-02-27Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMBiocon Pharma Inc.9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb2026-02-26Warnings, Adverse reactionsExact identifier
application number: ANDA209869
ndc (product): 70377-046
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
spl id: dc0074c0-e58a-3655-2a66-084168c39615
spl set id: 9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb
unii: 3M8608UQ61
FolartexMULTIVITAMINOncora Pharma, LLC0a4cb0ab-565f-45e8-a989-740bccef21cd2026-02-25Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
AfloraMULTIVITAMINOncora Pharma, LLC38e463d1-f608-7cb5-e063-6294a90a4abb2026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
FolixiaMULTIVITAMINOncora Pharma, LLC413945b5-116b-d8b6-e063-6394a90a55e82026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
NutralynMULTIVITAMINOncora Pharma, LLC33da017b-1e8c-d41c-e063-6394a90aab8c2026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
FolatenMULTIVITAMINOncora Pharma, LLC93086235-2c33-424d-b0c3-2130319885812026-02-12Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions2f658680-939a-4212-8a5e-a44a896dd2212026-02-11Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904467
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions3b9fe7c9-791e-49a0-a005-ccf13036c3652026-02-11Warnings, Adverse reactionsExact identifier
application number: ANDA209869
rxcui: 904467
unii: 3M8608UQ61
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackc0b1b483-1a19-4966-89b1-118ec660f2032026-01-29Warnings, Adverse reactionsExact identifier
rxcui: 904481
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAvPAKba4ac602-46fa-8386-e053-2995a90a97642026-01-09Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61

Reported adverse events (FAERS/openFDA)#

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