Mirtazapine

Product NDC
45865-361
11-digit product format
458650361
Labeler code
45865
Product ID
45865-361_715e69c6-f114-fd17-e053-2995a90a6c81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Medsource Pharmaceuitcals
Application
ANDA077666
Marketing category
ANDA
Marketing start
2007-08-22
Marketing end
0000-00-00
Substance
MIRTAZAPINE
Active strength
30 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
45865-361-302020-01-31C16284748780-19d75b9d0-36e2-f424-e053-dadaa90a57ceMIRTAZAPINE TABLETS, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-361-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-361MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUITCALS]1Legacy NDC, 1 package rows20180720_715e69c6-f113-fd17-e053-2995a90a6c81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314111mirtazapine 30 MG Oral TabletPSN715e69c6-f113-fd17-e053-2995a90a6c811
314111mirtazapine 30 MG Oral TabletSCD715e69c6-f113-fd17-e053-2995a90a6c811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-361-304586503613030 in 1 BOTTLEHistorical