FDA.reportPublic FDA data

pravastatin sodium

Product NDC
33261-867
11-digit product format
332610867
Labeler code
33261
Product ID
33261-867_74ec5981-fcf7-4164-a03f-2d6656a5f46f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077751
Marketing category
ANDA
Marketing start
2010-03-30
Marketing end
0000-00-00
Substance
PRAVASTATIN SODIUM
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
36361c23-a766-1581-d616-2080c781a50cProduct name520190314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-867-302020-01-31C16284748780-19d75b9d0-a255-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use pravastatin sodium safely and effectively. See full prescribing information for pravastatin sodium tablets. Initial U.S. Approval: 1991
33261-867-602020-01-31C16284748780-19d75b9d0-a255-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use pravastatin sodium safely and effectively. See full prescribing information for pravastatin sodium tablets. Initial U.S. Approval: 1991
33261-867-902020-01-31C16284748780-19d75b9d0-a255-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use pravastatin sodium safely and effectively. See full prescribing information for pravastatin sodium tablets. Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-867-30pravastatin sodium30 in 1 BOTTLE, PLASTICTABLET301
33261-867-60pravastatin sodium60 in 1 BOTTLE, PLASTICTABLET601
33261-867-90pravastatin sodium90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-867-30EA - Each33261-867dafe1c9d-c00e-4ebc-9232-749073d4cc5f12015-10-02
33261-867-60EA - Each33261-867563a78a4-b471-46d5-9b82-5e80b84d90bf12015-10-02
33261-867-90EA - Each33261-86759e66a0b-a296-44ea-8b8b-40b5251d94f512015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6OPRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-867PRAVASTATIN SODIUM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20140128_087a93d5-0e68-4856-86a3-28964f60d6ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSN087a93d5-0e68-4856-86a3-28964f60d6ff1
904475pravastatin sodium 40 MG Oral TabletPSN087a93d5-0e68-4856-86a3-28964f60d6ff1
904481pravastatin sodium 80 MG Oral TabletPSN087a93d5-0e68-4856-86a3-28964f60d6ff1
904467pravastatin sodium 20 MG Oral TabletSCD087a93d5-0e68-4856-86a3-28964f60d6ff1
904475pravastatin sodium 40 MG Oral TabletSCD087a93d5-0e68-4856-86a3-28964f60d6ff1
904481pravastatin sodium 80 MG Oral TabletSCD087a93d5-0e68-4856-86a3-28964f60d6ff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-867-303326108673030 in 1 BOTTLE, PLASTICHistorical
33261-867-603326108676060 in 1 BOTTLE, PLASTICHistorical
33261-867-903326108679090 in 1 BOTTLE, PLASTICHistorical