NDC Code(s) : 63629-9164-1, 63629-9164-2
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PRAVASTATIN SODIUMPRAVASTATIN SODIUM TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-9164(NDC:70377-047)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM(UNII: 3M8608UQ61)
(PRAVASTATIN - UNII:KXO2KT9N0G) 		PRAVASTATIN SODIUM40 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM OXIDE(UNII: 3A3U0GI71G)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Product Characteristics
Color WHITE (white to off -White) Score no score
Shape RECTANGLE (Rounded, Rectangle) Size 10 mm
Flavor Imprint Code B;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-9164-130 in 1 BOTTLE Type 0: Not a Combination Product02/04/2022
2NDC:63629-9164-260 in 1 BOTTLE Type 0: Not a Combination Product02/04/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209869 02/01/2021

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(63629-9164), RELABEL(63629-9164)

PRINCIPAL DISPLAY PANEL

Pravastatin Sodium Tablet 40 mg

Label