SEROQUEL (Page 12 of 12)

PACKAGE LABEL — SEROQUEL 100 MG TABS

SEROQUEL 100MG LABEL IMAGE
(click image for full-size original)

PACKAGE LABEL — SEROQUEL 400 MG TABS

SEROQUEL 400MG LABEL IMAGE
(click image for full-size original)

SEROQUEL quetiapine fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-520(NDC:0310-0271)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
QUETIAPINE FUMARATE (QUETIAPINE) QUETIAPINE FUMARATE 100 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
HYPROMELLOSES
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
WATER
Product Characteristics
Color yellow Score no score
Shape ROUND (BICONVEX) Size 9mm
Flavor Imprint Code SEROQUEL;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-520-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:16590-520-60 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:16590-520-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
4 NDC:16590-520-72 120 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020639 05/26/2011
SEROQUEL quetiapine fumarate tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-782(NDC:0310-0279)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Quetiapine fumarate (QUETIAPINE) Quetiapine fumarate 400 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
CELLULOSE, MICROCRYSTALLINE
SODIUM STARCH GLYCOLATE TYPE A POTATO
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
HYPROMELLOSES
POLYETHYLENE GLYCOL
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
WATER
Product Characteristics
Color yellow Score no score
Shape CAPSULE (BICONVEX) Size 19mm
Flavor Imprint Code SEROQUEL;400
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-782-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:16590-782-60 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
3 NDC:16590-782-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020639 05/26/2011
Labeler — STAT RX USA LLC (786036330)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 relabel, repack

Revised: 07/2011 STAT RX USA LLC

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