Mirtazapine

Product NDC
50090-4643
11-digit product format
500904643
Labeler code
50090
Product ID
50090-4643_3ffee2c5-dd60-4018-a01a-6cd3e6fc8a69
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
2004-10-22
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
50090-4643-02023-01-30C16284748780-1f386c64a-23ad-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
50090-4643-0Mirtazapine33 in 1 BOTTLETABLET, FILM COATED333

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4643MIRTAZAPINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]3Legacy NDC, 1 package rows20191107_1cc15904-4339-4816-ba1f-ad276f3f5209.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314111mirtazapine 30 MG Oral TabletPSN1cc15904-4339-4816-ba1f-ad276f3f52093
314111mirtazapine 30 MG Oral TabletSCD1cc15904-4339-4816-ba1f-ad276f3f52093

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4643-05009046430033 TABLET, FILM COATED in 1 BOTTLE (50090-4643-0) 2019-10-230000-00-00NoNoCurrent