Mirtazapine

Product NDC
64725-1117
11-digit product format
647251117
Labeler code
64725
Product ID
64725-1117_4b21397b-a3cf-4651-8b30-e80e8600e00c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA076312
Marketing category
ANDA
Marketing start
2003-06-19
Marketing end
0000-00-00
Substance
MIRTAZAPINE
Active strength
15 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64725-1117-12019-11-27C16284748780-19855e2a2-4d3a-60a7-e053-dbdaa90a05bdRevised: August 2014 Mirtazapine Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-1117-1Mirtazapine30 in 1 BOTTLETABLET, FILM COATED302

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64725-1117MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20140926_85f9b2ad-6f45-4625-954b-28a6d6bff517.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-1117-16472511170130 in 1 BOTTLEHistorical