Mirtazapine

Product NDC
50090-3083
11-digit product format
500903083
Labeler code
50090
Product ID
50090-3083_d1d5d6ad-ed0e-4c69-a85e-383dbba4ef5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076119
Marketing category
ANDA
Marketing start
2003-01-29
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
50090-3083-02020-01-31C16284748780-19d75b9d1-13c2-f424-e053-dadaa90a57ceMirtazapine Tablets USP 15 mg, 30 mg and 45 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3083-0Mirtazapine1 in 1 BLISTER PACKTABLET, FILM COATED121
50090-3083-0Mirtazapine33 in 1 BOX, UNIT-DOSETABLET, FILM COATED3321

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3083-0EA - Each50090-3083d439bdd1-fad1-4ce4-a5a7-6a1ba1e4751a12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3083MIRTAZAPINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]21Legacy NDC, 2 package rows20180920_1d4ca80a-5360-49d0-a3aa-b551b5b0de02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN1d4ca80a-5360-49d0-a3aa-b551b5b0de0221
314111mirtazapine 30 MG Oral TabletPSN1d4ca80a-5360-49d0-a3aa-b551b5b0de0221
311725mirtazapine 15 MG Oral TabletSCD1d4ca80a-5360-49d0-a3aa-b551b5b0de0221
314111mirtazapine 30 MG Oral TabletSCD1d4ca80a-5360-49d0-a3aa-b551b5b0de0221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-3083-0500903083001 in 1 BLISTER PACKHistorical