FDA.reportPublic FDA data

NDC 50090-4206-01 - 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
50090-4206
Requested NDC
50090-4206-01
Package NDCs from labels
50090-4206-0, 50090-4206-1, 50090-4206-01
Manufacturer
A-S Medication Solutions
Effective date
2023-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pravastatin Sodium - A-S Medication SolutionsA-S Medication Solutions2023-02-06HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-4206-02023-02-07These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
50090-4206-12023-02-07These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
50090-4206-02023-01-30These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991
50090-4206-12023-01-30These highlights do not include all the information needed to use PRAVASTATIN SODIUM TABLETS safely and effectively. See full prescribing information for PRAVASTATIN SODIUM TABLETS. PRAVASTATIN SODIUM tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4206-0Pravastatin Sodium30 in 1 BOTTLETABLET306
50090-4206-1Pravastatin Sodium90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4206PRAVASTATIN SODIUM TABLET [A-S MEDICATION SOLUTIONS]6Current NDC, Legacy NDC, 2 package rows20230208_4948e795-8c33-40e2-ae85-208962daee72.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4206-0EA - Each50090-42064b54d92f-7958-43dd-9ace-a35395ff383312022-01-06
50090-4206-1EA - Each50090-4206c49be4d9-ea9d-4313-a98b-029260c50c0e12022-01-06

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 7 of 8 · 143 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
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack24471777-5cd6-4c46-a5f2-a349fadc830e2024-04-04Warnings, Adverse reactionsExact identifier
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMDirect_Rx7f814fd9-7b35-67da-e053-2a91aa0a39dc2024-01-10Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMTeva Pharmaceuticals USA, Inc.99e0e848-f8f3-4b42-b880-8fbc426339482024-01-01Warnings, Adverse reactionsExact identifier
application number: ANDA076056
ndc (product): 0093-7202
rxcui: 904475
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMLupin Pharmaceuticals, Inc.1123d56c-16f0-4f81-b56f-67b1f343ae1e2023-12-19Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions4f9ada33-5592-4780-926d-1af49a8e064e2023-12-15Warnings, Adverse reactionsExact identifier
application number: ANDA076056
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutionsa75de063-c751-4647-bb9e-d4050c1e31fc2023-12-14Warnings, Adverse reactionsExact identifier
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMBryant Ranch Prepack70920620-37d6-4fe0-9d86-1fdffc2e6a992023-10-25Warnings, Adverse reactionsExact identifier
unii: 3M8608UQ61
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: H3R47K3TBD
PRAVASTATIN SODIUMPRAVASTATIN SODIUMProficient Rx LP4d2b4607-0a46-4b58-9247-dc448ce258ec2023-08-01Warnings, Adverse reactionsExact identifier
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMProficient Rx LP466e2d1a-a6d6-40f8-a9f6-3e7494a34ca62023-08-01Warnings, Adverse reactionsExact identifier
application number: ANDA076056
rxcui: 904475
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions4948e795-8c33-40e2-ae85-208962daee722023-02-06Warnings, Adverse reactionsExact identifier
application number: ANDA076056
ndc (package): 50090-4206-0
ndc (package): 50090-4206-1
ndc (product): 50090-4206
ndc11 (package): 50090420601
rxcui: 904475
spl id: e6c9596d-5162-46bf-8e61-a8ab610b06e4
spl set id: 4948e795-8c33-40e2-ae85-208962daee72
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMA-S Medication Solutions3a08fa97-24c3-4a4a-a0aa-26e50cbfc52d2023-02-06Warnings, Adverse reactionsExact identifier
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMGlenmark Pharmaceuticals Inc., USA6ca01de3-a0f9-4cfb-b36a-723c7c42e2a42022-07-08Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
Pravastatin SodiumPRAVASTATIN SODIUMTeva Pharmaceuticals, Inc.f66cb1c1-5ff1-4b0b-89d0-8ecaee26b0b82022-07-01Warnings, Adverse reactionsExact identifier
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMAphena Pharma Solutions - Tennessee, LLCce61f570-2564-429b-8775-157e8e32d3782022-03-03Warnings, Adverse reactionsExact identifier
unii: 3M8608UQ61
PRAVASTATIN SODIUMPRAVASTATIN SODIUMProficient Rx LP2bdfb0ef-2455-4ca2-a117-ce8e26bb2dbc2022-03-01Warnings, Adverse reactionsExact identifier
rxcui: 904475
unii: 3M8608UQ61
Melange combinationCALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEASeroyal USA0a071fbf-0075-4479-e054-00144ff8d46c2021-07-14WarningsExact identifier
unii: L11K75P92J

Reported adverse events (FAERS/openFDA)#

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