FDA.reportPublic FDA data

NDC 68788-7660-08 - 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
68788-7660
Requested NDC
68788-7660-08
Package NDCs from labels
68788-7660-2, 68788-7660-3, 68788-7660-6, 68788-7660-9, 68788-7660-0, 68788-7660-8, 68788-7660-08
Manufacturer
Preferred Pharmaceuticals Inc..
Effective date
2026-08-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PRAVASTATIN SODIUM - Preferred Pharmaceuticals Inc..Preferred Pharmaceuticals Inc..2026-08-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7660-0PRAVASTATIN SODIUM100 in 1 BOTTLETABLET1004
68788-7660-2PRAVASTATIN SODIUM20 in 1 BOTTLETABLET204
68788-7660-3PRAVASTATIN SODIUM30 in 1 BOTTLETABLET304
68788-7660-6PRAVASTATIN SODIUM60 in 1 BOTTLETABLET604
68788-7660-8PRAVASTATIN SODIUM120 in 1 BOTTLETABLET1204
68788-7660-9PRAVASTATIN SODIUM90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7660PRAVASTATIN SODIUM TABLET [PREFERRED PHARMACEUTICALS INC..]3Current NDC, Legacy NDC, 6 package rows20240731_ebd794ba-90c3-4d81-9c45-4aa9d9454359.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7660-2EA - Each68788-766063eee21a-d605-4482-a601-5d718f31f99912022-10-06
68788-7660-3EA - Each68788-76604e1b9414-3b36-43cb-a035-ba01faa626f812022-10-06
68788-7660-6EA - Each68788-766095e2ad77-f32d-4dc6-9aed-4f410f508fa912022-10-06
68788-7660-8EA - Each68788-7660999ca148-81f8-496d-97a8-f040ff885a4112022-10-06
68788-7660-9EA - Each68788-7660e382dd78-c206-4d13-be30-0d0c002c1fd312022-10-06

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 1 of 7 · 122 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
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
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
ndc (package): 68788-7660-0
ndc (package): 68788-7660-9
ndc (package): 68788-7660-2
ndc (package): 68788-7660-6
ndc (package): 68788-7660-8
ndc (package): 68788-7660-3
ndc (product): 68788-7660
ndc11 (package): 68788766008
rxcui: 904481
spl id: 418c65fd-0357-4974-87ae-7246a23b87cb
spl set id: ebd794ba-90c3-4d81-9c45-4aa9d9454359
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
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): 60505-1323
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
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.c5f611aa-9974-422e-a353-5d834a33937c2026-07-07Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.8dbdc80d-9d8c-4e22-9108-d87a77e07a6b2026-07-07Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904475
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMSafecor Health LLC0ae196a4-be3d-4cd8-9ff2-68aeb91b86782026-07-01Warnings, Adverse reactionsExact identifier
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAmerican Health Packaging97f826f0-b5c5-410c-b1f0-523873981e8d2026-06-17Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackca7a4143-0091-4cd5-9061-cb05cc84ea4e2026-06-16Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepackf074240e-ef6b-45f2-8c4d-cb5c0dbc81f12026-06-11Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCardinal Health 107, LLC9289f9ed-b6e3-4e81-bdb8-6aedbd5288a92026-06-11Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61

Reported adverse events (FAERS/openFDA)#

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