Mirtazapine

Product NDC
64725-0247
11-digit product format
647250247
Labeler code
64725
Product ID
64725-0247_b7a6199a-9010-4f2d-8887-f701d6e7068b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TYA Pharmaceuticals
Application
ANDA077666
Marketing category
ANDA
Marketing start
2007-08-22
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
64725-0247-12020-01-31C16284748780-19d75b9d0-e8ff-f424-e053-dadaa90a57ceMirtazapine Tablets, USP 15 mg, 30 mg and 45 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64725-0247-1Mirtazapine30 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
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BMIRTAZAPINE 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
64725-0247MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2Legacy NDC, 1 package rows20141110_424a0710-3ce6-40a1-ada2-c1e4a8578d0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN424a0710-3ce6-40a1-ada2-c1e4a8578d0f2
311725mirtazapine 15 MG Oral TabletSCD424a0710-3ce6-40a1-ada2-c1e4a8578d0f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64725-0247-16472502470130 in 1 BOTTLEHistorical