Prescription Drug Information: Mirtazapine (Page 8 of 8)

MIRTAZAPINE TABLET, FILM COATED

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MIRTAZAPINE TABLET, FILM COATED

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MIRTAZAPINE
mirtazapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-098(NDC:60505-0247)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIRTAZAPINE (MIRTAZAPINE) MIRTAZAPINE 15 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color yellow Score 2 pieces
Shape OVAL Size 9mm
Flavor Imprint Code APO;MI;15
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-098-10 10 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX (63739-098-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077666 08/22/2007
MIRTAZAPINE
mirtazapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-099(NDC:60505-0248)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIRTAZAPINE (MIRTAZAPINE) MIRTAZAPINE 30 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 8000
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
Product Characteristics
Color pink Score 2 pieces
Shape OVAL Size 11mm
Flavor Imprint Code APO;MI;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-099-10 10 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the BOX (63739-099-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077666 08/22/2007
Labeler — McKesson Corporation dba SKY Packaging (140529962)
Establishment
Name Address ID/FEI Operations
Legacy Pharmaceutical Packaging, LLC 143213275 repack (63739-098), repack (63739-099), relabel (63739-098), relabel (63739-099)

Revised: 11/2020 McKesson Corporation dba SKY Packaging

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