FDA.reportPublic FDA data

NDC 67046-1621-03 - 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
67046-1621
Requested NDC
67046-1621-03
Package NDCs from labels
67046-1621-3, 67046-1621-03
Manufacturer
Coupler LLC | Apotex Inc.
Effective date
2025-12-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PRAVASTATIN SODIUM - Coupler LLC | Apotex Inc.Coupler LLC | Apotex Inc.2025-12-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-1621-3PRAVASTATIN SODIUM30 in 1 BLISTER PACKTABLET301

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 1 of 10 · 185 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pravastatin sodiumPRAVASTATIN SODIUMREMEDYREPACK INC.6cef5e92-26b7-435c-878f-72a05a6245602026-09-10Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Pravastatin sodiumPRAVASTATIN SODIUMREMEDYREPACK INC.fa152ce7-6c07-4aaf-9374-932ce81d0cf92026-09-04Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCIPLA USA INC.678dfe58-3200-4c3d-9718-365aa47d070f2026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.5ecd9fd1-7662-412d-99c5-13c77188748c2026-08-21Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMREMEDYREPACK INC.e4dbaa72-7b3e-4aef-983b-90efb2b343cd2026-08-21Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.6d42bd30-1f09-49f4-9ec8-31366df1b4b42026-08-17Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.46cdd32d-a022-4acf-ba2b-10e7877d56c62026-08-17Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc..ebd794ba-90c3-4d81-9c45-4aa9d94543592026-08-17Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904481
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.095ac6fd-fdfb-4207-b15d-8e93bee378c32026-08-17Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCardinal Health 107, LLC3e218ad6-5b47-4cca-81be-ebaea57959642026-08-13Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904458
unii: 3M8608UQ61
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
PRAVASTATIN SODIUMPRAVASTATIN SODIUMQuallente9c188f7-cd6f-afac-b493-36552d86589e2026-08-03Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMApotex Corp.dcf45e4f-b46e-6fbb-b67a-2ff619ab17802026-07-31Warnings, Adverse reactionsExact identifier
application number: ANDA076341
ndc (product): 60505-0168
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
spl id: 23a54cde-a404-07d5-9a4f-e7297930c0e5
spl set id: dcf45e4f-b46e-6fbb-b67a-2ff619ab1780
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMAurobindo Pharma Limitedb06ed801-ddee-4f56-924a-59fcb451eae62026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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