NDC Code(s) : 71205-026-03, 71205-026-30, 71205-026-60, 71205-026-90
Packager : Proficient Rx LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

QuetiapineQuetiapine TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-026(NDC:0093-8164)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI) 		QUETIAPINE300 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POVIDONE K25(UNII: K0KQV10C35)
POVIDONE K27(UNII: H7AGY1OJO8)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color YELLOW (pale yellow) Score no score
Shape OVAL (capsule-shaped) Size 19 mm
Flavor Imprint Code 93;8164
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71205-026-0303 in 1 BOTTLE Type 0: Not a Combination Product05/01/2018
2NDC:71205-026-3030 in 1 BOTTLE Type 0: Not a Combination Product05/01/2018
3NDC:71205-026-6060 in 1 BOTTLE Type 0: Not a Combination Product05/01/2018
4NDC:71205-026-9090 in 1 BOTTLE Type 0: Not a Combination Product05/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077745 03/27/2012

LABELER - Proficient Rx LP(079196022)

Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079196022 REPACK(71205-026), RELABEL(71205-026)

PRINCIPAL DISPLAY PANEL

71205-026-30