Prescription Drug Information: Mirtazapine (Page 6 of 6)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 7.5 mg

PRINCIPAL DISPLAY PANEL
(click image for full-size original)
MIRTAZAPINE mirtazapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0615-8489(NDC:57237-007)
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
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
SILICON DIOXIDE
LACTOSE MONOHYDRATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Product Characteristics
Color white Score no score
Shape CAPSULE (Biconvex) Size 7mm
Flavor Imprint Code 11;A
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-8489-39 30 TABLET, FILM COATED in 1 BLISTER PACK None
2 NDC:0615-8489-05 15 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076921 10/22/2004
Labeler — NCS HealthCare of KY, LLC dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Operations
NCS HealthCare of KY, LLC dba Vangard Labs 050052943 repack (0615-8489)

Revised: 09/2023 NCS HealthCare of KY, LLC dba Vangard Labs

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