FDA.reportPublic FDA data

Mirtazapine

Product NDC
63629-5086
11-digit product format
636295086
Labeler code
63629
Product ID
63629-5086_3bde04e7-1aea-4890-8c98-ea1d26434c20
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077376
Marketing category
ANDA
Marketing start
2005-12-08
Marketing end
0000-00-00
Substance
MIRTAZAPINE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ca5a24a-fafa-8fc8-52ac-b403ff18faa5Product name320240216
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
a733d273-402b-1005-9891-1ac1a9c63703Product name220170724
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-5086-12024-05-17C16284748780-19d75b9d0-82e7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MIRTAZAPINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE ORALLY DISINTEGRATING TABLETS. MIRTAZAPINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1996
63629-5086-12024-01-30C16284748780-19d75b9d0-82e7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MIRTAZAPINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE ORALLY DISINTEGRATING TABLETS. MIRTAZAPINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1996
63629-5086-12020-10-16C16284748780-19d75b9d0-82e7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MIRTAZAPINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE ORALLY DISINTEGRATING TABLETS. MIRTAZAPINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1996
63629-5086-12020-01-31C16284748780-19d75b9d0-82e7-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use MIRTAZAPINE ORALLY DISINTEGRATING TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE ORALLY DISINTEGRATING TABLETS. MIRTAZAPINE orally disintegrating tablets, for oral use Initial U.S. Approval: 1996

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000
MANNITOLINACTIVE INGREDIENT3OWL53L36AMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1000

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5086MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]1006Legacy NDC20240518_3bde04e7-1aea-4890-8c98-ea1d26434c20.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-5086-16362950860130 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63629-5086-1) 2013-09-040000-00-00NoNoCurrent