NDC Code(s) : 68071-3463-6
Packager : NuCare Pharmaceuticals,Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

QUETIAPINE FUMARATEQUETIAPINE FUMARATE TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-3463(NDC:16729-132)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE(UNII: 2S3PL1B6UJ)
(QUETIAPINE - UNII:BGL0JSY5SI) 		QUETIAPINE50 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2208 (4000 MPA.S)(UNII: 39J80LT57T)
HYPROMELLOSE 2208 (100 MPA.S)(UNII: B1QE5P712K)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POVIDONE K30(UNII: U725QWY32X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color orange (peach) Score no score
Shape CAPSULE (biconvex) Size 16 mm
Flavor Imprint Code AB1
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68071-3463-660 in 1 BOTTLE Type 0: Not a Combination Product19/07/2023
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206252 11/30/2017

LABELER - NuCare Pharmaceuticals,Inc.(010632300)

Establishment
Name Address ID/FEI Business Operations
NuCare Pharmaceuticals,Inc. 010632300 relabel(68071-3463)

PRINCIPAL DISPLAY PANEL

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