Mirtazapine

Product NDC
43353-614
11-digit product format
433530614
Labeler code
43353
Product ID
43353-614_a8065d90-4130-414c-8b4b-17d5855067b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076921
Marketing category
ANDA
Marketing start
2009-08-17
Marketing end
0000-00-00
Substance
MIRTAZAPINE
Active strength
45 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-614-30Mirtazapine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-614MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Legacy NDC, 1 package rows20191224_75dd7e5b-32ec-433b-8379-11cfb372f0d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN75dd7e5b-32ec-433b-8379-11cfb372f0d03
314111mirtazapine 30 MG Oral TabletPSN75dd7e5b-32ec-433b-8379-11cfb372f0d03
311726mirtazapine 45 MG Oral TabletPSN75dd7e5b-32ec-433b-8379-11cfb372f0d03
311725mirtazapine 15 MG Oral TabletSCD75dd7e5b-32ec-433b-8379-11cfb372f0d03
314111mirtazapine 30 MG Oral TabletSCD75dd7e5b-32ec-433b-8379-11cfb372f0d03
311726mirtazapine 45 MG Oral TabletSCD75dd7e5b-32ec-433b-8379-11cfb372f0d03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-614-304335306143030 in 1 BOTTLE, PLASTICHistorical