NDC Code(s) : 29300-301-13, 29300-302-13
Packager : Unichem Pharmaceuticals (USA), Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Prasugrel Prasugrel TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-301
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRASUGREL HYDROCHLORIDE(UNII: G89JQ59I13)
(PRASUGREL - UNII:34K66TBT99) 		PRASUGREL5 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)(UNII: NZ94SDL6WR)
MANNITOL(UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE 102(UNII: PNR0YF693Y)
SUCROSE STEARATE(UNII: 274KW0O50M)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color YELLOW (Light yellow to yellowish) Score no score
Shape CAPSULE Size 8 mm
Flavor Imprint Code U;301
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:29300-301-1330 in 1 BOTTLE Type 0: Not a Combination Product16/10/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213315 10/16/2023
Prasugrel Prasugrel TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29300-302
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRASUGREL HYDROCHLORIDE(UNII: G89JQ59I13)
(PRASUGREL - UNII:34K66TBT99) 		PRASUGREL10 mg
Inactive Ingredients
Ingredient Name Strength
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE (11% HYDROXYPROPYL; 120000 MW)(UNII: NZ94SDL6WR)
MANNITOL(UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE 102(UNII: PNR0YF693Y)
SUCROSE STEARATE(UNII: 274KW0O50M)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color BROWN (Light brown to brown) Score no score
Shape CAPSULE Size 11 mm
Flavor Imprint Code U;302
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:29300-302-1330 in 1 BOTTLE Type 0: Not a Combination Product16/10/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213315 10/16/2023

LABELER - Unichem Pharmaceuticals (USA), Inc.(181620514)

PRINCIPAL DISPLAY PANEL

Container LabelContainer Label - Prasugrel Tablets 5 mg - 30 Tablets Container LabelContainer Label - Prasugrel Tablets 10 mg - 30 Tablets