Mirtazapine

Product NDC
52959-902
11-digit product format
529590902
Labeler code
52959
Product ID
52959-902_6dadb3b7-2077-4b27-b8b6-529e8698deca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
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
E
Listing certified through
2018-12-31
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
52959-902-302020-01-31C16284748780-19d75b9d0-f8ce-f424-e053-dadaa90a57ceMirtazapine Tablets, USP 30 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-902-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-902MIRTAZAPINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2Legacy NDC, 1 package rows20111221_18a9c172-7081-484a-8c3b-bde9b2e54e95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314111mirtazapine 30 MG Oral TabletPSN18a9c172-7081-484a-8c3b-bde9b2e54e952
314111mirtazapine 30 MG Oral TabletSCD18a9c172-7081-484a-8c3b-bde9b2e54e952

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-902-305295909023030 in 1 BOTTLEHistorical