Mirtazapine

Product NDC
50090-4123
11-digit product format
500904123
Labeler code
50090
Product ID
50090-4123_93825c5a-2de8-41d3-b706-bd8901406e32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076921
Marketing category
ANDA
Marketing start
2009-08-17
Marketing end
0000-00-00
Substance
MIRTAZAPINE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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
50090-4123-02023-01-30C16284748780-1f386c64a-19f2-0266-e053-dadaa90a7c1aMirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4123-0Mirtazapine1 in 1 BLISTER PACKTABLET, FILM COATED11
50090-4123-0Mirtazapine33 in 1 BOX, UNIT-DOSETABLET, FILM COATED331

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4123MIRTAZAPINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20190209_74a3f517-63eb-4e33-b75f-ef59ce14c1c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314111mirtazapine 30 MG Oral TabletPSN74a3f517-63eb-4e33-b75f-ef59ce14c1c81
314111mirtazapine 30 MG Oral TabletSCD74a3f517-63eb-4e33-b75f-ef59ce14c1c81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4123-05009041230033 BLISTER PACK in 1 BOX, UNIT-DOSE (50090-4123-0) > 1 TABLET, FILM COATED in 1 BLISTER PACK33 blister pack2019-02-040000-00-00NoNoCurrent