FDA.reportPublic FDA data

Mirtazapine

Product NDC
53002-2712
11-digit product format
530022712
Labeler code
53002
Product ID
53002-2712_794f1537-395a-4081-9a83-f99e35a11637
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA076921
Marketing category
ANDA
Marketing start
2004-10-22
Marketing end
0000-00-00
Substance
MIRTAZAPINE
Active strength
45 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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
53002-2712-32025-01-30C16284748780-1f386c649-c3a1-0266-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
53002-2712-92025-01-30C16284748780-1f386c649-c3a1-0266-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
53002-2712-32023-06-07C16284748780-1f386c649-c3a1-0266-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
53002-2712-92023-06-07C16284748780-1f386c649-c3a1-0266-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
53002-2712-32023-01-30C16284748780-1f386c649-c3a1-0266-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
53002-2712-92023-01-30C16284748780-1f386c649-c3a1-0266-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
53002-2712-3Mirtazapine30 in 1 BOTTLETABLET, FILM COATED303
53002-2712-9Mirtazapine90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2712MIRTAZAPINE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20230609_3d63f74b-8069-45f7-9cf6-10b8ad628ff0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311726mirtazapine 45 MG Oral TabletPSN3d63f74b-8069-45f7-9cf6-10b8ad628ff03
311726mirtazapine 45 MG Oral TabletSCD3d63f74b-8069-45f7-9cf6-10b8ad628ff03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-2712-35300227120330 TABLET, FILM COATED in 1 BOTTLE (53002-2712-3) 2019-01-010000-00-00NoNoCurrent
53002-2712-95300227120990 TABLET, FILM COATED in 1 BOTTLE (53002-2712-9) 2019-01-010000-00-00NoNoCurrent