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 3 of 6 · 119 matching rows.

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

Reported adverse events (FAERS/openFDA)#

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