FDA.reportPublic FDA data

Mirtazapine

Product NDC
65862-032
11-digit product format
658620032
Labeler code
65862
Product ID
65862-032_e26778b1-5226-4107-9d12-3e8b7038bccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA076921
Marketing category
ANDA
Marketing start
2004-10-22
Substance
MIRTAZAPINE
Active strength
45 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
MIRTAZAPINE45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui311725, 311726, 314111, 476809

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ca5a24a-fafa-8fc8-52ac-b403ff18faa5Product name320240216
a733d273-402b-1005-9891-1ac1a9c63703Product name220170724

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65862-032-01Mirtazapine100 in 1 BOTTLETABLET, FILM COATED10019
65862-032-05Mirtazapine500 in 1 BOTTLETABLET, FILM COATED50019
65862-032-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3019
65862-032-32Mirtazapine30 in 1 BLISTER PACKTABLET, FILM COATED3019
65862-032-60Mirtazapine60 in 1 BOTTLETABLET, FILM COATED6019
65862-032-90Mirtazapine90 in 1 BOTTLETABLET, FILM COATED9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-032-01EA - Each65862-032f366e85d-06ab-454a-8396-491a660fc21b12012-07-24
65862-032-05EA - Each65862-032b7ca483b-33fb-422f-9fa6-24466fe0433a12012-07-24
65862-032-30EA - Each65862-032cffee4bc-2fb1-43c7-a0f1-7d5abd0d27d612012-07-24
65862-032-90EA - Each65862-0328926d680-b9d7-439c-acb8-165c3a8bc5fc12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]9
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-032MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]18Current NDC, Legacy NDC, 6 package rows20240126_a4c012f0-50b6-42fb-9f06-a14632f23f2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSNa4c012f0-50b6-42fb-9f06-a14632f23f2e19
314111mirtazapine 30 MG Oral TabletPSNa4c012f0-50b6-42fb-9f06-a14632f23f2e19
311726mirtazapine 45 MG Oral TabletPSNa4c012f0-50b6-42fb-9f06-a14632f23f2e19
476809mirtazapine 7.5 MG Oral TabletPSNa4c012f0-50b6-42fb-9f06-a14632f23f2e19
311725mirtazapine 15 MG Oral TabletSCDa4c012f0-50b6-42fb-9f06-a14632f23f2e19
314111mirtazapine 30 MG Oral TabletSCDa4c012f0-50b6-42fb-9f06-a14632f23f2e19
311726mirtazapine 45 MG Oral TabletSCDa4c012f0-50b6-42fb-9f06-a14632f23f2e19
476809mirtazapine 7.5 MG Oral TabletSCDa4c012f0-50b6-42fb-9f06-a14632f23f2e19
311725mirtazapine 15 MG Oral TabletPSN18fbbcbb-73bd-4d22-8f4e-9a2777f0daf81
314111mirtazapine 30 MG Oral TabletPSN18fbbcbb-73bd-4d22-8f4e-9a2777f0daf81
311726mirtazapine 45 MG Oral TabletPSN18fbbcbb-73bd-4d22-8f4e-9a2777f0daf81
311725mirtazapine 15 MG Oral TabletSCD18fbbcbb-73bd-4d22-8f4e-9a2777f0daf81
314111mirtazapine 30 MG Oral TabletSCD18fbbcbb-73bd-4d22-8f4e-9a2777f0daf81
311726mirtazapine 45 MG Oral TabletSCD18fbbcbb-73bd-4d22-8f4e-9a2777f0daf81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-032-0165862003201100 TABLET, FILM COATED in 1 BOTTLE (65862-032-01) 2004-10-220000-00-00NoNoCurrent
65862-032-0565862003205500 TABLET, FILM COATED in 1 BOTTLE (65862-032-05) 2004-10-220000-00-00NoNoCurrent
65862-032-306586200323030 TABLET, FILM COATED in 1 BOTTLE (65862-032-30) 2004-10-220000-00-00NoNoCurrent
65862-032-326586200323230 TABLET, FILM COATED in 1 BLISTER PACK (65862-032-32) 2004-10-220000-00-00NoNoCurrent
65862-032-39658620032393000 TABLET, FILM COATED in 1 BAG (65862-032-39)22-OCT-04Current
65862-032-606586200326060 TABLET, FILM COATED in 1 BOTTLE (65862-032-60) 2004-10-220000-00-00NoNoCurrent
65862-032-906586200329090 TABLET, FILM COATED in 1 BOTTLE (65862-032-90) 2004-10-220000-00-00NoNoCurrent