FDA.reportPublic FDA data

NDC 70518-0876-00 - 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
70518-0876
Requested NDC
70518-0876-00
Package NDCs from labels
70518-0876-0, 70518-0876-1, 70518-0876-2, 70518-0876-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-21
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.2026-08-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-0876-0PRAVASTATIN SODIUM90 in 1 BOTTLE, PLASTICTABLET9020
70518-0876-1PRAVASTATIN SODIUM30 in 1 BLISTER PACKTABLET3020
70518-0876-2PRAVASTATIN SODIUM45 in 1 BOTTLE, PLASTICTABLET4520

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0876PRAVASTATIN SODIUM TABLET [REMEDYREPACK INC.]15Current NDC, Legacy NDC, 3 package rows20250503_5ecd9fd1-7662-412d-99c5-13c77188748c.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 7 · 122 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNuCare Pharmaceuticals,Inc.8ed7879d-988c-1a27-e053-2995a90a03612024-06-18Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904458
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack73633a65-93b9-46dd-8f9f-d4b5c00890402024-06-05Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack24471777-5cd6-4c46-a5f2-a349fadc830e2024-04-04Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMDirect_Rx7f814fd9-7b35-67da-e053-2a91aa0a39dc2024-01-10Warnings, Adverse reactionsExact identifier
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMTeva Pharmaceuticals USA, Inc.99e0e848-f8f3-4b42-b880-8fbc426339482024-01-01Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.1123d56c-16f0-4f81-b56f-67b1f343ae1e2023-12-19Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions4f9ada33-5592-4780-926d-1af49a8e064e2023-12-15Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutionsa75de063-c751-4647-bb9e-d4050c1e31fc2023-12-14Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack70920620-37d6-4fe0-9d86-1fdffc2e6a992023-10-25Warnings, Adverse reactionsExact identifier
rxcui: 904481
unii: 3M8608UQ61
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: H3R47K3TBD
PRAVASTATIN SODIUMPRAVASTATIN SODIUMProficient Rx LP4d2b4607-0a46-4b58-9247-dc448ce258ec2023-08-01Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904467
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMProficient Rx LP466e2d1a-a6d6-40f8-a9f6-3e7494a34ca62023-08-01Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions4948e795-8c33-40e2-ae85-208962daee722023-02-06Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d2023-02-06Warnings, Adverse reactionsExact identifier
rxcui: 904481
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMGlenmark Pharmaceuticals Inc., USA6ca01de3-a0f9-4cfb-b36a-723c7c42e2a42022-07-08Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMTeva Pharmaceuticals, Inc.f66cb1c1-5ff1-4b0b-89d0-8ecaee26b0b82022-07-01Warnings, Adverse reactionsExact identifier
rxcui: 904481
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAphena Pharma Solutions - Tennessee, LLCce61f570-2564-429b-8775-157e8e32d3782022-03-03Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904481
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMProficient Rx LP2bdfb0ef-2455-4ca2-a117-ce8e26bb2dbc2022-03-01Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904475
unii: 3M8608UQ61

Reported adverse events (FAERS/openFDA)#

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