Pravastatin Sodium

Product NDC
42291-669
11-digit product format
422910669
Labeler code
42291
Product ID
42291-669_ec190869-82b8-6c7f-e053-2a95a90a8577
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA077793
Marketing category
ANDA
Marketing start
2014-06-30
Marketing end
0000-00-00
Substance
PRAVASTATIN SODIUM
Active strength
80 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-669-10EA - Each42291-6696b75e240-8675-419b-a2ef-f09efdc47ed412014-09-03
42291-669-45EA - Each42291-66939bec5f3-e36e-4152-be77-62e15fe4fd0112014-11-05
42291-669-90EA - Each42291-6693c9f8ec6-a38e-4bdd-844c-bdffbe3fd35b12014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PRAVASTATIN SODIUMACTIVE INGREDIENT3M8608UQ61PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]2
PRAVASTATINACTIVE MOIETYKXO2KT9N0GPRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]2
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JPRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKPRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]2
Ferric Oxide RedINACTIVE INGREDIENT1K09F3G675PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30PRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XPRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIPRAVASTATIN SODIUM (PRAVASTATIN SODIUM) TABLET [AVKARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-669PRAVASTATIN SODIUM TABLET [AVKARE]12Legacy NDC20230913_345979e5-647b-7898-a933-e43a25250627.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-669-10422910669101000 TABLET in 1 BOTTLE (42291-669-10) 1000 tablet2014-06-300000-00-00NoNoCurrent
42291-669-454229106694545 TABLET in 1 BOTTLE (42291-669-45) 45 tablet2014-06-300000-00-00NoNoCurrent
42291-669-904229106699090 TABLET in 1 BOTTLE (42291-669-90) 90 tablet2014-06-300000-00-00NoNoCurrent