pravastatin sodium

Product NDC
63187-413
11-digit product format
631870413
Labeler code
63187
Product ID
63187-413_2fd93eac-64e3-4d40-b8d5-68034e16e717
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pravastatin sodium
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM TABLET [PROFICIENT RX LP]2
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM TABLET [PROFICIENT RX LP]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPRAVASTATIN SODIUM TABLET [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM TABLET [PROFICIENT RX LP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM TABLET [PROFICIENT RX LP]2
POLYOXYL 35 CASTOR OILINACTIVE INGREDIENT6D4M1DAL6OPRAVASTATIN SODIUM TABLET [PROFICIENT RX LP]2
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TPRAVASTATIN SODIUM TABLET [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-413PRAVASTATIN SODIUM TABLET [PROFICIENT RX LP]4Legacy NDC20210115_d9311ea1-dfa8-4f00-94ef-84b8a41d51ee.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-413-306318704133030 TABLET in 1 BOTTLE (63187-413-30) 30 tablet2019-01-010000-00-00NoNoCurrent