FDA.reportPublic FDA data

NDC 0591-0013 - 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
0591-0013
Package NDCs from labels
0591-0013-19
Manufacturer
Watson Laboratories, Inc.
Effective date
2008-10-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pravastatin Sodium TabletsWatson Laboratories, Inc.2008-10-06HUMAN PRESCRIPTION DRUG LABELING

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-0013PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]3Unmatched20081121_AD3DA3C3-66B2-09FE-2C85-AAF4367E3732.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
pravastatin sodiumACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]3
pravastatinACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]3
croscramellose sodiumINACTIVE INGREDIENTPRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]3
Green Lake Blend (mixture of D&C Yellow No. 10-Aluminum Lake and FD&C Blue No. 1-Aluminum Lake)INACTIVE INGREDIENTPRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]3
lactoseINACTIVE INGREDIENTJ2B2A4N98GPRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]3
magnesium oxideINACTIVE INGREDIENT3A3U0GI71GPRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]3
magnesium stearateINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]3
microcrystalline celluloseINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]3
povidoneINACTIVE INGREDIENTFZ989GH94EPRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]3
Red Ferric OxideINACTIVE INGREDIENT1K09F3G675PRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]3
Yellow Ferric OxideINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM TABLET [WATSON LABORATORIES, INC.]3

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 2 of 6 · 119 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack14390bfa-3bcb-43e1-936c-1977cb37427d2026-06-04Warnings, Adverse reactionsExact identifier
rxcui: 904475
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack8d1bf7a5-bf11-47e3-afca-dcc13f2d30682026-06-04Warnings, Adverse reactionsExact identifier
rxcui: 904467
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackd0641def-425e-4357-a6b6-24ce004245492026-06-01Warnings, Adverse reactionsExact identifier
rxcui: 904467
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackdcf46d0c-87da-4009-b238-eb5cf287c3ed2026-05-29Warnings, Adverse reactionsExact identifier
rxcui: 904475
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.2ded7e5e-c377-4495-a045-f1c57b90c5db2026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 904467
PRAVASTATIN SODIUMPRAVASTATIN SODIUMPD-Rx Pharmaceuticals, Inc.46fdf929-c961-4dd9-8865-8eb4adaa259a2026-05-21Warnings, Adverse reactionsExact identifier
rxcui: 904475
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackdaacdad5-f75d-4f9f-b623-8071f3bef91e2026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 904467
Pravastatin SodiumPRAVASTATIN SODIUMAmici Pharma, Inc.e6551230-fe4c-4a6e-9c19-ae9945b76db02026-05-19Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
Pravastatin sodiumPRAVASTATIN SODIUMGolden State Medical Supply, Inc.25b7276e-a69f-af63-e063-6394a90aecf22026-04-21Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNorthwind Health Company, LLC4fad5d73-aa79-58f2-e063-6294a90af4aa2026-04-16Warnings, Adverse reactionsExact identifier
rxcui: 904458
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutions93b0e546-9e0f-40d1-9b1e-082bf16400a42026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 904467
rxcui: 904475
PRAVASTATIN SODIUMPRAVASTATIN SODIUMA-S Medication Solutionsd69e8af8-dbd4-43d9-8e9a-4aed3923a17c2026-04-13Warnings, Adverse reactionsExact identifier
rxcui: 904475
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutionsb7f8c679-a602-4268-81b6-962a136a4e432026-04-02Warnings, Adverse reactionsExact identifier
rxcui: 904467
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions8df47d82-5b09-414d-99f1-7ac4c77f7c012026-04-02Warnings, Adverse reactionsExact identifier
rxcui: 904467
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackf4b330ce-dfb0-4e4e-9f37-482458820c662026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 904458
PRAVASTATIN SODIUMPRAVASTATIN SODIUMNCS HealthCare of KY, LLC dba Vangard Labs64ccb4b5-b77e-4b23-8c74-4685287edb4b2026-02-27Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
Pravastatin sodiumPRAVASTATIN SODIUMBiocon Pharma Inc.9bd4a493-1f75-e33a-53fb-4e2fbc64a1eb2026-02-26Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions2f658680-939a-4212-8a5e-a44a896dd2212026-02-11Warnings, Adverse reactionsExact identifier
rxcui: 904467
Pravastatin sodiumPRAVASTATIN SODIUMA-S Medication Solutions3b9fe7c9-791e-49a0-a005-ccf13036c3652026-02-11Warnings, Adverse reactionsExact identifier
rxcui: 904467
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepackc0b1b483-1a19-4966-89b1-118ec660f2032026-01-29Warnings, Adverse reactionsExact identifier
rxcui: 904481

Reported adverse events (FAERS/openFDA)#

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