FDA.reportPublic FDA data

NDC 0591-0016 - 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
0591-0016
Package NDCs from labels
0591-0016-19
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
0591-0016PRAVASTATIN 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 6 of 6 · 119 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack73633a65-93b9-46dd-8f9f-d4b5c00890402024-06-05Warnings, Adverse reactionsExact identifier
rxcui: 904458
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack24471777-5cd6-4c46-a5f2-a349fadc830e2024-04-04Warnings, Adverse reactionsExact identifier
rxcui: 904467
Pravastatin SodiumPRAVASTATIN SODIUMDirect_Rx7f814fd9-7b35-67da-e053-2a91aa0a39dc2024-01-10Warnings, Adverse reactionsExact identifier
rxcui: 904467
rxcui: 904475
Pravastatin SodiumPRAVASTATIN SODIUMTeva Pharmaceuticals USA, Inc.99e0e848-f8f3-4b42-b880-8fbc426339482024-01-01Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904467
rxcui: 904475
PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.1123d56c-16f0-4f81-b56f-67b1f343ae1e2023-12-19Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions4f9ada33-5592-4780-926d-1af49a8e064e2023-12-15Warnings, Adverse reactionsExact identifier
rxcui: 904467
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutionsa75de063-c751-4647-bb9e-d4050c1e31fc2023-12-14Warnings, Adverse reactionsExact identifier
rxcui: 904467
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack70920620-37d6-4fe0-9d86-1fdffc2e6a992023-10-25Warnings, Adverse reactionsExact identifier
rxcui: 904481
PRAVASTATIN SODIUMPRAVASTATIN SODIUMProficient Rx LP4d2b4607-0a46-4b58-9247-dc448ce258ec2023-08-01Warnings, Adverse reactionsExact identifier
rxcui: 904467
Pravastatin SodiumPRAVASTATIN SODIUMProficient Rx LP466e2d1a-a6d6-40f8-a9f6-3e7494a34ca62023-08-01Warnings, Adverse reactionsExact identifier
rxcui: 904475
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions4948e795-8c33-40e2-ae85-208962daee722023-02-06Warnings, Adverse reactionsExact identifier
rxcui: 904475
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d2023-02-06Warnings, Adverse reactionsExact identifier
rxcui: 904481
Pravastatin SodiumPRAVASTATIN SODIUMGlenmark Pharmaceuticals Inc., USA6ca01de3-a0f9-4cfb-b36a-723c7c42e2a42022-07-08Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
Pravastatin SodiumPRAVASTATIN SODIUMTeva Pharmaceuticals, Inc.f66cb1c1-5ff1-4b0b-89d0-8ecaee26b0b82022-07-01Warnings, Adverse reactionsExact identifier
rxcui: 904481
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAphena Pharma Solutions - Tennessee, LLCce61f570-2564-429b-8775-157e8e32d3782022-03-03Warnings, Adverse reactionsExact identifier
rxcui: 904481
PRAVASTATIN SODIUMPRAVASTATIN SODIUMProficient Rx LP2bdfb0ef-2455-4ca2-a117-ce8e26bb2dbc2022-03-01Warnings, Adverse reactionsExact identifier
rxcui: 904475
PRAVASTATIN SODIUMPRAVASTATIN SODIUMProficient Rx LP63ca6179-6ae3-4f0b-bdca-50d2003179212019-10-01Warnings, Adverse reactionsExact identifier
rxcui: 904475
Pravastatin sodiumPRAVASTATIN SODIUMDr.Reddy's Laboratories Limited99cc0546-bb2d-751e-edfd-1c15a1182e0c2018-11-21Warnings, Adverse reactionsExact identifier
rxcui: 904458
rxcui: 904481
rxcui: 904467
rxcui: 904475
E1E780E6-FFFB-6B02-2930-4381EE7BC608AD3DA3C3-66B2-09FE-2C85-AAF4367E37322008-10-06Warnings, Adverse reactionsExact identifier
spl id: E1E780E6-FFFB-6B02-2930-4381EE7BC608
spl set id: AD3DA3C3-66B2-09FE-2C85-AAF4367E3732

Reported adverse events (FAERS/openFDA)#

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