FDA.reportPublic FDA data

Mirtazapine

Product NDC
57237-012
11-digit product format
572370012
Labeler code
57237
Product ID
57237-012_ed2cd1df-697f-4e63-8097-7802be5eb6bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA077376
Marketing category
ANDA
Marketing start
2005-12-08
Substance
MIRTAZAPINE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mirtazapine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRTAZAPINE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui283406, 283407, 283485

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-012-06Mirtazapine5 in 1 CARTONTABLET, ORALLY DISINTEGRATING514
57237-012-06Mirtazapine6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING614

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-012-06EA - Each57237-0126cd6d3ec-6694-4d15-a76a-eb373a9f724212014-04-03

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
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
ASPARTAMEINACTIVE INGREDIENTZ0H242BBR1MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AMIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [CITRON PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-012MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [RISING PHARMA HOLDINGS, INC.]13Current NDC, Legacy NDC, 2 package rows20240201_73b7bbd9-7dba-4559-890f-3f8dd821e215.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283406mirtazapine 15 MG Disintegrating Oral TabletPSN73b7bbd9-7dba-4559-890f-3f8dd821e21514
283407mirtazapine 30 MG Disintegrating Oral TabletPSN73b7bbd9-7dba-4559-890f-3f8dd821e21514
283485mirtazapine 45 MG Disintegrating Oral TabletPSN73b7bbd9-7dba-4559-890f-3f8dd821e21514
283406mirtazapine 15 MG Disintegrating Oral TabletSCD73b7bbd9-7dba-4559-890f-3f8dd821e21514
283407mirtazapine 30 MG Disintegrating Oral TabletSCD73b7bbd9-7dba-4559-890f-3f8dd821e21514
283485mirtazapine 45 MG Disintegrating Oral TabletSCD73b7bbd9-7dba-4559-890f-3f8dd821e21514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57237-012-06572370012065 BLISTER PACK in 1 CARTON (57237-012-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK5 blister pack2005-12-080000-00-00NoNoCurrent