pravastatin sodium

Product NDC
68382-072
11-digit product format
683820072
Labeler code
68382
Product ID
68382-072_12014495-c66a-407e-aa7b-5c58596230ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA077751
Marketing category
ANDA
Marketing start
2010-03-30
Marketing end
0000-00-00
Substance
PRAVASTATIN SODIUM
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-072-05EA - Each68382-07227fc519e-af27-4e6c-8461-f772b84a90a512012-07-24
68382-072-16EA - Each68382-072fd886bae-f3aa-455b-98fc-8f04f445bd2b12012-07-24

DailyMed Socrata Ingredients#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
904467pravastatin sodium 20 MG Oral TabletPSN087a93d5-0e68-4856-86a3-28964f60d6ff1
904467pravastatin sodium 20 MG Oral TabletPSN5318e92a-aa98-4890-870e-e4dec3f6069e1
904475pravastatin sodium 40 MG Oral TabletPSN087a93d5-0e68-4856-86a3-28964f60d6ff1
904475pravastatin sodium 40 MG Oral TabletPSN5318e92a-aa98-4890-870e-e4dec3f6069e1
904481pravastatin sodium 80 MG Oral TabletPSN087a93d5-0e68-4856-86a3-28964f60d6ff1
904467pravastatin sodium 20 MG Oral TabletSCD087a93d5-0e68-4856-86a3-28964f60d6ff1
904467pravastatin sodium 20 MG Oral TabletSCD5318e92a-aa98-4890-870e-e4dec3f6069e1
904475pravastatin sodium 40 MG Oral TabletSCD087a93d5-0e68-4856-86a3-28964f60d6ff1
904475pravastatin sodium 40 MG Oral TabletSCD5318e92a-aa98-4890-870e-e4dec3f6069e1
904481pravastatin sodium 80 MG Oral TabletSCD087a93d5-0e68-4856-86a3-28964f60d6ff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-072-0568382007205500 TABLET in 1 BOTTLE (68382-072-05) 500 tablet2010-03-300000-00-00NoNoCurrent
68382-072-166838200721690 TABLET in 1 BOTTLE (68382-072-16) 90 tablet2010-03-300000-00-00NoNoCurrent