FDA.reportPublic FDA data

Mirtazapine

Product NDC
65862-021
11-digit product format
658620021
Labeler code
65862
Product ID
65862-021_04494335-fcd8-47b2-a573-98a214f07ff6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA077376
Marketing category
ANDA
Marketing start
2005-12-08
Substance
MIRTAZAPINE
Active strength
15 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
MIRTAZAPINE15 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
65862-021-01Mirtazapine100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10021
65862-021-06Mirtazapine6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING621
65862-021-06Mirtazapine5 in 1 CARTONTABLET, ORALLY DISINTEGRATING521
65862-021-30Mirtazapine30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING3021
65862-021-60Mirtazapine60 in 1 BOTTLETABLET, ORALLY DISINTEGRATING6021
65862-021-90Mirtazapine90 in 1 BOTTLETABLET, ORALLY DISINTEGRATING9021

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-021MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [AUROBINDO PHARMA LIMITED]20Current NDC, Legacy NDC, 6 package rows20240126_3a8a4490-9243-4201-944d-cea27d3d69f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283406mirtazapine 15 MG Disintegrating Oral TabletPSN3a8a4490-9243-4201-944d-cea27d3d69f521
283407mirtazapine 30 MG Disintegrating Oral TabletPSN3a8a4490-9243-4201-944d-cea27d3d69f521
283485mirtazapine 45 MG Disintegrating Oral TabletPSN3a8a4490-9243-4201-944d-cea27d3d69f521
283406mirtazapine 15 MG Disintegrating Oral TabletSCD3a8a4490-9243-4201-944d-cea27d3d69f521
283407mirtazapine 30 MG Disintegrating Oral TabletSCD3a8a4490-9243-4201-944d-cea27d3d69f521
283485mirtazapine 45 MG Disintegrating Oral TabletSCD3a8a4490-9243-4201-944d-cea27d3d69f521
283406mirtazapine 15 MG Disintegrating Oral TabletPSN5127517f-b8d0-4af1-8a2f-5225719600bc6
283406mirtazapine 15 MG Disintegrating Oral TabletSCD5127517f-b8d0-4af1-8a2f-5225719600bc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-021-0165862002101100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-01) 2005-12-080000-00-00NoNoCurrent
65862-021-06658620021065 BLISTER PACK in 1 CARTON (65862-021-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK5 blister pack2005-12-080000-00-00NoNoCurrent
65862-021-306586200213030 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-30) 2005-12-080000-00-00NoNoCurrent
65862-021-606586200216060 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-60) 2005-12-080000-00-00NoNoCurrent
65862-021-81658620021818000 TABLET, ORALLY DISINTEGRATING in 1 BAG (65862-021-81)08-DEC-05Current
65862-021-906586200219090 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65862-021-90) 2005-12-080000-00-00NoNoCurrent