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 9 of 13 · 251 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCoupler LLC2e0655ba-b1ba-789b-e063-6294a90a0a192025-02-13Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCoupler LLC2e07ad78-1059-e0ec-e063-6394a90a9bff2025-02-13Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMNuCare Pharmaceuticals, Inc.2d40e473-f79a-e50e-e063-6294a90a4d9e2025-02-03Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMChartwell RX, LLCf87016fb-4c01-4279-8cf7-59819971ca152025-01-30Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack7b900a28-f20e-49d5-98a9-5513fee0a9012025-01-30Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMDIRECT RX97178675-3691-2d93-e053-2995a90aa5c12025-01-17Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
Magnesium OxideMAGNESIUM OXIDERichmond Pharmaceuticals, Inc.9119b7f0-3e8a-7be7-e053-2995a90a46342024-12-26WarningsExact identifier
unii: 3A3U0GI71G
Magnesium OxideMAGNESIUM OXIDERichmond Pharmaceuticals, Inc.db5941b2-0a04-452a-8fbc-bd5e40fadfb12024-12-26WarningsExact identifier
unii: 3A3U0GI71G
Pravastatin SodiumPRAVASTATIN SODIUMQuality Care Products, LLC465dc828-966e-4bb4-b935-ef26583dd4e62024-12-19Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMLake Erie Medical DBA Quality Care Products LLCe7194af1-6304-4e3e-88ab-0825706a39622024-12-11Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNCS HealthCare of KY, LLC dba Vangard Labs27ba8a69-b5aa-40eb-89f7-6bf2c1fcceae2024-12-06Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
VentrixylFOLIC ACIDPureTek Corporationc29dc729-93be-2a20-e053-2a95a90a8ca32024-12-03Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
Folitin-ZFERROUS FUMARATE, FOLIC ACIDPureTek Corporationbb141ac2-e5df-4df4-e053-2995a90a6e722024-12-02Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
FoliflexFERROUS FUMARATE, FOLIC ACIDPureTek Corporationcba98d1a-8cf9-39d9-e053-2995a90ae8bb2024-11-27Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G
FinazolFERROUS FUMARATE, FOLATEPureTek Corporation24290823-022a-433b-e063-6394a90a8fd02024-11-07Warnings, Adverse reactionsExact identifier
unii: 3A3U0GI71G

Reported adverse events (FAERS/openFDA)#

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