FDA.reportPublic FDA data

Mirtazapine

Product NDC
65862-001
11-digit product format
658620001
Labeler code
65862
Product ID
65862-001_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
7.5 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
MIRTAZAPINE7.5 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
65862-001-01Mirtazapine100 in 1 BOTTLETABLET, FILM COATED10019
65862-001-05Mirtazapine500 in 1 BOTTLETABLET, FILM COATED50019
65862-001-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3019
65862-001-60Mirtazapine60 in 1 BOTTLETABLET, FILM COATED6019
65862-001-90Mirtazapine90 in 1 BOTTLETABLET, FILM COATED9019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-001-01EA - Each65862-001dbb7c195-1b84-4597-8409-0e38eeb7795012012-07-24
65862-001-05EA - Each65862-001ad1dbb98-c14a-4136-bfdb-caa3ab9acdda12012-07-24
65862-001-30EA - Each65862-00165208ae5-c482-4041-b462-6686a12664ab12012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-001MIRTAZAPINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]18Current NDC, Legacy NDC, 5 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-001-0165862000101100 TABLET, FILM COATED in 1 BOTTLE (65862-001-01) 2004-10-220000-00-00NoNoCurrent
65862-001-0565862000105500 TABLET, FILM COATED in 1 BOTTLE (65862-001-05) 2004-10-220000-00-00NoNoCurrent
65862-001-306586200013030 TABLET, FILM COATED in 1 BOTTLE (65862-001-30) 2004-10-220000-00-00NoNoCurrent
65862-001-606586200016060 TABLET, FILM COATED in 1 BOTTLE (65862-001-60) 2004-10-220000-00-00NoNoCurrent
65862-001-906586200019090 TABLET, FILM COATED in 1 BOTTLE (65862-001-90) 2004-10-220000-00-00NoNoCurrent