Home NDC 0591-1119
Mirtazapine
Product NDC 0591-1119
11-digit product format 005911119
Labeler code 0591
Product ID 0591-1119_7efd691f-59a7-4fae-961f-68b7fc609a7d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Mirtazapine
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA076312
Marketing category ANDA
Marketing start 2003-06-19
Marketing end 2020-03-31
Substance MIRTAZAPINE
Active strength 45 mg/1
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record DailyMed Product Concepts#
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MIRTAZAPINE ACTIVE INGREDIENT A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 MIRTAZAPINE ACTIVE INGREDIENT A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MIRTAZAPINE ACTIVE MOIETY A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 MIRTAZAPINE ACTIVE MOIETY A051Q2099Q MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSE 2910 (3 MPA.S) INACTIVE INGREDIENT 0VUT3PMY82 MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC] 1
DailyMed RxNorm Mappings#