Mirtazapine

Product NDC
0591-1117
11-digit product format
005911117
Labeler code
0591
Product ID
0591-1117_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
15 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ca5a24a-fafa-8fc8-52ac-b403ff18faa5Product name320240216
a733d273-402b-1005-9891-1ac1a9c63703Product name220170724

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-1117-10EA - Each0591-11179a6472fd-df3e-436c-8b18-a3226daf4aa012012-07-24
0591-1117-30EA - Each0591-1117cf26699f-bdd8-4474-862c-31fc67e6678212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC]1
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC]1
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC]1
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [STAT RX USA LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN85f9b2ad-6f45-4625-954b-28a6d6bff5172
311725mirtazapine 15 MG Oral TabletSCD85f9b2ad-6f45-4625-954b-28a6d6bff5172
311725mirtazapine 15 MG Oral TabletPSN2373655d-ac74-43f5-a041-9f41a5b922061
311725mirtazapine 15 MG Oral TabletPSNdd2f25f6-7688-48e1-92e7-aab152ff74131
314111mirtazapine 30 MG Oral TabletPSN2373655d-ac74-43f5-a041-9f41a5b922061
314111mirtazapine 30 MG Oral TabletPSNdd2f25f6-7688-48e1-92e7-aab152ff74131
311726mirtazapine 45 MG Oral TabletPSNdd2f25f6-7688-48e1-92e7-aab152ff74131
311725mirtazapine 15 MG Oral TabletSCD2373655d-ac74-43f5-a041-9f41a5b922061
311725mirtazapine 15 MG Oral TabletSCDdd2f25f6-7688-48e1-92e7-aab152ff74131
314111mirtazapine 30 MG Oral TabletSCD2373655d-ac74-43f5-a041-9f41a5b922061
314111mirtazapine 30 MG Oral TabletSCDdd2f25f6-7688-48e1-92e7-aab152ff74131
311726mirtazapine 45 MG Oral TabletSCDdd2f25f6-7688-48e1-92e7-aab152ff74131