Quetiapine Fumarate (Page 13 of 13)

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QUETIAPINE FUMARATE quetiapine fumarate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-941(NDC:67877-242)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE (QUETIAPINE) QUETIAPINE 25 mg
Inactive Ingredients
Ingredient Name Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE K30
MAGNESIUM STEARATE
HYPROMELLOSE 2910 (6 MPA.S)
POLYETHYLENE GLYCOL 4000
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color PINK (peach) Score no score
Shape ROUND (biconvex) Size 6mm
Flavor Imprint Code 262
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55700-941-30 30 TABLET in 1 BOTTLE None
2 NDC:55700-941-90 90 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201504 09/10/2021
Labeler — Quality Care Products, LLC (831276758)
Establishment
Name Address ID/FEI Operations
Quality Care Products, LLC 831276758 repack (55700-941)

Revised: 02/2023 Quality Care Products, LLC

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