FDA.reportPublic FDA data

NDC 55154-7998-00 - 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
55154-7998
Requested NDC
55154-7998-00
Package NDCs from labels
55154-7998-0, 55154-7998-00
Manufacturer
Cardinal Health 107, LLC
Effective date
2026-06-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PRAVASTATIN SODIUM - Cardinal Health 107, LLCCardinal Health 107, LLC2026-06-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-7998-0PRAVASTATIN SODIUM10 in 1 BAGTABLET1010
55154-7998-0PRAVASTATIN SODIUM1 in 1 BLISTER PACKTABLET110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7998PRAVASTATIN SODIUM TABLET [CARDINAL HEALTH 107, LLC]9Current NDC, Legacy NDC, 2 package rows20250403_9289f9ed-b6e3-4e81-bdb8-6aedbd5288a9.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 1 of 6 · 119 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 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
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMPreferred Pharmaceuticals Inc.095ac6fd-fdfb-4207-b15d-8e93bee378c32026-08-17Warnings, Adverse reactionsExact identifier
rxcui: 904467
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMCardinal Health 107, LLC3e218ad6-5b47-4cca-81be-ebaea57959642026-08-13Warnings, Adverse reactionsExact identifier
application number: ANDA076341
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMQuallente9c188f7-cd6f-afac-b493-36552d86589e2026-08-03Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMApotex Corp.dcf45e4f-b46e-6fbb-b67a-2ff619ab17802026-07-31Warnings, Adverse reactionsExact identifier
application number: ANDA076341
rxcui: 904467
rxcui: 904475
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMAurobindo Pharma Limitedb06ed801-ddee-4f56-924a-59fcb451eae62026-07-29Warnings, Adverse reactionsExact identifier
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: 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
ndc (package): 55154-7998-0
ndc (package): 55154-7275-0
ndc (product): 55154-7275
ndc (product): 55154-7998
ndc11 (package): 55154799800
rxcui: 904467
rxcui: 904475
spl id: e407ab16-299c-4159-a9a1-4a999c95bd46
spl set id: 9289f9ed-b6e3-4e81-bdb8-6aedbd5288a9
unii: 3M8608UQ61
Pravastatin sodiumPRAVASTATIN SODIUMBryant Ranch Prepack3686a2df-51c4-4f1c-9d1e-d692079151442026-06-11Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61

Reported adverse events (FAERS/openFDA)#

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