FDA.reportPublic FDA data

Mirtazapine

Product NDC
50090-1057
11-digit product format
500901057
Labeler code
50090
Product ID
50090-1057_d395de56-30b0-499f-93f6-116e1fd8c26c
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
2009-08-17
Marketing end
0000-00-00
Substance
MIRTAZAPINE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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
50090-1057-02023-02-07C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
50090-1057-02023-02-07C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
50090-1057-12023-02-07C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
50090-1057-12023-02-07C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
50090-1057-22023-02-07C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
50090-1057-22023-02-07C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
50090-1057-32023-02-07C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
50090-1057-32023-02-07C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
50090-1057-02023-01-30C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
50090-1057-02023-01-30C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
50090-1057-12023-01-30C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
50090-1057-12023-01-30C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
50090-1057-22023-01-30C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
50090-1057-22023-01-30C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
50090-1057-32023-01-30C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
50090-1057-32023-01-30C16284748780-1f386c649-9e6f-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1057-0Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3021
50090-1057-1Mirtazapine15 in 1 BOTTLETABLET, FILM COATED1521
50090-1057-2Mirtazapine60 in 1 BOTTLETABLET, FILM COATED6021
50090-1057-3Mirtazapine90 in 1 BOTTLETABLET, FILM COATED9021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1057-0EA - Each50090-105731119181-8e75-45c0-9553-b385c5b16a0c12021-08-05
50090-1057-2EA - Each50090-1057f0e52f93-0f0c-49c3-8c34-2a76910447ec12021-08-05
50090-1057-3EA - Each50090-1057276cf4f1-d453-44ec-8a03-12a6a429a41c12021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1057MIRTAZAPINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]16Legacy NDC, 4 package rows20230208_67e753ad-9919-416b-9e8f-aab0fa808066.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN67e753ad-9919-416b-9e8f-aab0fa80806621
314111mirtazapine 30 MG Oral TabletPSN67e753ad-9919-416b-9e8f-aab0fa80806621
311725mirtazapine 15 MG Oral TabletSCD67e753ad-9919-416b-9e8f-aab0fa80806621
314111mirtazapine 30 MG Oral TabletSCD67e753ad-9919-416b-9e8f-aab0fa80806621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1057-05009010570030 TABLET, FILM COATED in 1 BOTTLE (50090-1057-0) 2014-11-280000-00-00NoNoCurrent
50090-1057-15009010570115 TABLET, FILM COATED in 1 BOTTLE (50090-1057-1) 2019-10-290000-00-00NoNoCurrent
50090-1057-25009010570260 TABLET, FILM COATED in 1 BOTTLE (50090-1057-2) 2014-11-280000-00-00NoNoCurrent
50090-1057-35009010570390 TABLET, FILM COATED in 1 BOTTLE (50090-1057-3) 2014-11-280000-00-00NoNoCurrent