Mirtazapine (Page 9 of 9)

PRINCIPAL DISPLAY PANEL-7.5mg

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MIRTAZAPINE
mirtazapine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-494(NDC:57664-510)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MIRTAZAPINE (MIRTAZAPINE) MIRTAZAPINE 7.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE
STARCH, CORN
MAGNESIUM STEARATE
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
HYPROMELLOSE, UNSPECIFIED
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Product Characteristics
Color yellow Score no score
Shape ROUND (CIRCULAR) Size 6mm
Flavor Imprint Code C
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-494-30 30 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076541 08/02/2022
Labeler — AvKARE (796560394)

Revised: 08/2022 AvKARE

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