NDC Code(s) : 63629-9165-1, 63629-9165-2
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:63629-9165(NDC:70377-048)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAVASTATIN SODIUM(UNII: 3M8608UQ61)
(PRAVASTATIN - UNII:KXO2KT9N0G) 		PRAVASTATIN SODIUM80 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 OVAL Size 17 mm
Flavor Imprint Code B;80
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:63629-9165-130 in 1 BOTTLE Type 0: Not a Combination Product02/04/2022
2NDC:63629-9165-260 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(63629-9165), RELABEL(63629-9165)

PRINCIPAL DISPLAY PANEL

Pravastatin Sodium Tablet 80 mg

Label