NDC Code(s) : 76237-401-30
Packager : McKesson Contract Packaging

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Quetiapine FumarateQuetiapine Fumarate TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76237-401(NDC:0093-8162)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI) 		QUETIAPINE100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE(UNII: O7TSZ97GEP)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POVIDONE K25(UNII: K0KQV10C35)
POVIDONE K26/28(UNII: H7AGY1OJO8)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
ALUMINUM OXIDE(UNII: LMI26O6933)
Product Characteristics
Color ORANGE (light orange) Score no score
Shape ROUND Size 8 mm
Flavor Imprint Code 93;8162
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:76237-401-305 in 1 BOX, UNIT-DOSE 10/03/2016
16 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077745 03/27/2012

PRINCIPAL DISPLAY PANEL

Quetiapine Tablets USP 100 mg 100s Label