Mirtazapine: Package Insert and Label Information (Page 5 of 5)

Mirtazapine

Label ImageLabel Image

Mirtazapine

Label ImageLabel Image
MIRTAZAPINE mirtazapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2558(NDC:57237-009)
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
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
SILICON DIOXIDE
LACTOSE MONOHYDRATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
FERRIC OXIDE RED
FERROSOFERRIC OXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color BROWN (Reddish Brown) Score 2 pieces
Shape CAPSULE (Biconvex) Size 14mm
Flavor Imprint Code 0;9;A
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-2558-2 60 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:50090-2558-0 30 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:50090-2558-3 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076921 10/22/2004
MIRTAZAPINE mirtazapine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-2800(NDC:57237-008)
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
STARCH, CORN
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED
MAGNESIUM STEARATE
SILICON DIOXIDE
LACTOSE MONOHYDRATE
HYPROMELLOSE 2910 (6 MPA.S)
TITANIUM DIOXIDE
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score 2 pieces
Shape CAPSULE (Biconvex) Size 9mm
Flavor Imprint Code 0;8;A
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-2800-0 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:50090-2800-1 90 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076921 10/22/2004
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-2558), REPACK (50090-2558), RELABEL (50090-2800), REPACK (50090-2800)

Revised: 08/2022 A-S Medication Solutions

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.