Pravastatin Sodium

Product NDC
42291-667
11-digit product format
422910667
Labeler code
42291
Product ID
42291-667_ec190869-82b8-6c7f-e053-2a95a90a8577
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pravastatin Sodium
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA076056
Marketing category
ANDA
Marketing start
2014-06-30
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
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
42291-667-10EA - Each42291-66773e1c345-a014-4be6-94cc-75c970da4c7a12014-09-03
42291-667-90EA - Each42291-66705a278c5-0a0f-4ad4-b893-1c5ac76529c112014-09-03

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
42291-667PRAVASTATIN 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
42291-667-10422910667101000 TABLET in 1 BOTTLE (42291-667-10) 1000 tablet2014-06-300000-00-00NoNoCurrent
42291-667-904229106679090 TABLET in 1 BOTTLE (42291-667-90) 90 tablet2014-06-300000-00-00NoNoCurrent