Quetiapine fumarate tablet, film coated

Ingredients and appearance - Product information

Quetiapine fumarate tablet, film coated- Quetiapine fumarate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 55154-3379
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Quetiapine fumarate ( UNII: 2S3PL1B6UJ)( Quetiapine - UNII: BGL0JSY5SI ) 25 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Dibasic calcium phosphate dihydrate ( UNII: O7TSZ97GEP)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Povidone, unspecified ( UNII: FZ989GH94E)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Hypromellose 2910 (5 mpa.s) ( UNII: R75537T0T4)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Titanium dioxide ( UNII: 15FIX9V2JP)
Ferric oxide yellow ( UNII: EX438O2MRT)

Product Characteristics

Color WHITE Size 5 mm
Shape ROUND Score 1
Imprint Code R;1

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077380 USA

Quetiapine fumarate tablet, film coated- Quetiapine fumarate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 55154-7648
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Quetiapine fumarate ( UNII: 2S3PL1B6UJ)( Quetiapine - UNII: BGL0JSY5SI ) 50 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Dibasic calcium phosphate dihydrate ( UNII: O7TSZ97GEP)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Povidone, unspecified ( UNII: FZ989GH94E)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Hypromellose 2910 (5 mpa.s) ( UNII: R75537T0T4)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Titanium dioxide ( UNII: 15FIX9V2JP)
Ferric oxide yellow ( UNII: EX438O2MRT)

Product Characteristics

Color WHITE Size 7 mm
Shape ROUND Score 1
Imprint Code R;2

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077380 USA

Quetiapine fumarate tablet, film coated- Quetiapine fumarate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 55154-3380
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Quetiapine fumarate ( UNII: 2S3PL1B6UJ)( Quetiapine - UNII: BGL0JSY5SI ) 100 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Dibasic calcium phosphate dihydrate ( UNII: O7TSZ97GEP)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Povidone, unspecified ( UNII: FZ989GH94E)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Hypromellose 2910 (5 mpa.s) ( UNII: R75537T0T4)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Titanium dioxide ( UNII: 15FIX9V2JP)
Ferric oxide yellow ( UNII: EX438O2MRT)

Product Characteristics

Color YELLOW Size 10 mm
Shape ROUND Score 1
Imprint Code R;3

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077380 USA

Quetiapine fumarate tablet, film coated- Quetiapine fumarate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 55154-3381
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Quetiapine fumarate ( UNII: 2S3PL1B6UJ)( Quetiapine - UNII: BGL0JSY5SI ) 200 mgin 1

Inactive Ingredients

Ingredient Name Code
Silicon dioxide ( UNII: ETJ7Z6XBU4)
Dibasic calcium phosphate dihydrate ( UNII: O7TSZ97GEP)
Lactose monohydrate ( UNII: EWQ57Q8I5X)
Magnesium stearate ( UNII: 70097M6I30)
Microcrystalline cellulose ( UNII: OP1R32D61U)
Povidone, unspecified ( UNII: FZ989GH94E)
Sodium starch glycolate type a potato ( UNII: 5856J3G2A2)
Hypromellose 2910 (5 mpa.s) ( UNII: R75537T0T4)
Polyethylene glycol 400 ( UNII: B697894SGQ)
Titanium dioxide ( UNII: 15FIX9V2JP)
Ferric oxide yellow ( UNII: EX438O2MRT)

Product Characteristics

Color WHITE Size 12 mm
Shape ROUND Score 1
Imprint Code R;5

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077380 USA

Labeler - Cardinal Health( 603638201)

Establishment

Name ID/FEI Business Operations
Cardinal Health 603638201 REPACK( 55154-3379, 55154-7648, 55154-3380, 55154-3381)

Package/label display panel

Quetiapine Fumarate Tablets

25 mg.*

10 Tablets

Package/label display panel

Quetiapine Fumarate Tablets

100 mg*

10 Tablets

Package/label display panel

Quetiapine Fumarate Tablets

100 mg.*

10 Tablets

Package/label display panel

Quetiapine Fumarate Tablets

200 mg.*

10 Tablets