NDC 70518-4339-01 - 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
70518-4339
Requested NDC
70518-4339-01
Package NDCs from labels
70518-4339-0, 70518-4339-1, 70518-4339-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pravastatin sodium - REMEDYREPACK INC.REMEDYREPACK INC.2026-09-04HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4339-0Pravastatin sodium30 in 1 BLISTER PACKTABLET303
70518-4339-1Pravastatin sodium90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4339PRAVASTATIN SODIUM TABLET [REMEDYREPACK INC.]1Current NDC, 2 package rows20250523_fa152ce7-6c07-4aaf-9374-932ce81d0cf9.zip

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 8 · 143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAphena Pharma Solutions - Tennessee, LLC2e5c8a1c-b36f-d124-e063-6394a90a6fb52025-02-17Warnings, Adverse reactionsExact identifier
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAphena Pharma Solutions - Tennessee, LLC2e5cfae8-20b8-1fea-e063-6394a90a4e172025-02-17Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
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
application number: ANDA076056
rxcui: 904467
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMChartwell RX, LLCf87016fb-4c01-4279-8cf7-59819971ca152025-01-30Warnings, Adverse reactionsExact identifier
rxcui: 904458
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: 904467
rxcui: 904475
unii: 3M8608UQ61
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: 904467
rxcui: 904475
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions55f8cf43-bf8b-4729-9e5a-32fcc9696e022024-10-30Warnings, Adverse reactionsExact identifier
application number: ANDA076056
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutions7b4ef7a8-47e5-428f-91de-7307dcbb91672024-10-23Warnings, Adverse reactionsExact identifier
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack6bb60d07-0787-4d5f-8a8c-1224d5b02b2b2024-08-30Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack06d85243-f9df-4984-b3d3-fcd8a7c554e92024-08-20Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack01beb7e2-ba01-4f2f-8554-4a8ec0941c9f2024-08-14Warnings, Adverse reactionsExact identifier
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNuCare Pharmaceuticals, Inc.54228087-7ab0-5561-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNuCare Pharmaceuticals,Inc.548bdd9f-dcc6-28c7-e054-00144ff8d46c2024-07-10Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNuCare Pharmaceuticals,Inc.8e9d5896-0b7c-dbd4-e053-2a95a90ae2f62024-06-18Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNuCare Pharmaceuticals,Inc.8ed7879d-988c-1a27-e053-2995a90a03612024-06-18Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61

Reported adverse events (FAERS/openFDA)#

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