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 3 of 7 · 122 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAvPAKba4ac602-46fa-8386-e053-2995a90a97642026-01-09Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutions3e6d1c1e-d5f7-42ec-bcdd-8fc310acdf212026-01-06Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904458
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMNorthwind Health Company, LLC40aa2d36-57ce-1f48-e063-6294a90affef2026-01-02Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMNorthwind Health Company, LLCdb0e9c21-dc25-629a-e053-2a95a90a5ac32026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNorthwind Health Company, LLCdb5b8821-dca8-9322-e053-2a95a90abdc32026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNorthwind Health Company, LLCdf75b04e-3e85-9705-e053-2995a90af83f2026-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904481
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMNorthwind Health Company, LLC47207487-0c6d-8da3-e063-6294a90a8aee2025-12-29Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMNorthwind Health Company, LLC471b4dac-057d-740c-e063-6294a90af9e92025-12-19Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutionsfd76794d-de33-4886-875c-fa05b2639f842025-12-10Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCoupler LLC4573c42b-6d4a-e001-e063-6294a90acea12025-12-08Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904458
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.f92e12bc-40c3-4afa-9190-2f4de11ec6b32025-12-08Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack12943de2-c7e9-4651-89f3-fc6cb52766762025-11-17Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack97123f09-b5ad-45c2-8bb7-f50566b56b082025-11-17Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904481
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack2ba7af14-9c87-4eb0-84c9-7e895cd75fae2025-11-14Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904458
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAccord Healthcare Inc.6c011348-a236-47d3-bbef-3e0b956dd0802025-11-14Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepack4ed7a4d1-1183-4d95-8311-6d3e58feafa82025-11-10Warnings, Adverse reactionsExact identifier
rxcui: 904458
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepack91c5b5c8-3379-4b84-aff7-ef6cfc65fe9f2025-11-10Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackabcfc343-7ac9-4fce-b368-fd05cf14b0e22025-11-04Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904481
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.e6a3d99c-c9cc-49d9-b0f9-503770307b702025-10-31Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack03e27551-b3bf-47dd-b3ec-cd9a66ace3c42025-10-30Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904467
unii: 3M8608UQ61

Reported adverse events (FAERS/openFDA)#

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