Mirtazapine

Product NDC
13107-031
11-digit product format
131070031
Labeler code
13107
Product ID
13107-031_4329eeed-8071-4b6c-887d-0cd00647b84c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurolife Pharma LLC
Application
ANDA076921
Marketing category
ANDA
Marketing start
2009-08-17
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
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
13107-031-01Mirtazapine100 in 1 BOTTLETABLET, FILM COATED10014
13107-031-05Mirtazapine500 in 1 BOTTLETABLET, FILM COATED50014
13107-031-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3014
13107-031-32Mirtazapine30 in 1 BLISTER PACKTABLET, FILM COATED3014
13107-031-34Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3014
13107-031-60Mirtazapine60 in 1 BOTTLETABLET, FILM COATED6014
13107-031-90Mirtazapine90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-031-05EA - Each13107-03184c341d9-10f7-4255-84f4-26c9903ab83d12012-07-24
13107-031-30EA - Each13107-0314e545c96-ecde-4a27-96ce-7e96563d07d312012-07-24
13107-031-34EA - Each13107-031404a7f5b-d899-4fd7-ac56-2d74a266fb0912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MirtazapineACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]7
MirtazapineACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]7
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]7
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]7
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]7
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]7
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]7
MirtazapineACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
MirtazapineACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]5
MirtazapineACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MirtazapineACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14MIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-031MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]13Current NDC, Legacy NDC, 7 package rows20240126_aa05d606-29fd-443e-802b-1d65584d6bb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN67e753ad-9919-416b-9e8f-aab0fa80806621
314111mirtazapine 30 MG Oral TabletPSN67e753ad-9919-416b-9e8f-aab0fa80806621
311725mirtazapine 15 MG Oral TabletSCD67e753ad-9919-416b-9e8f-aab0fa80806621
314111mirtazapine 30 MG Oral TabletSCD67e753ad-9919-416b-9e8f-aab0fa80806621
311725mirtazapine 15 MG Oral TabletPSN82a615a0-e74a-49cb-9a57-ffbb3df604d514
311725mirtazapine 15 MG Oral TabletPSNaa05d606-29fd-443e-802b-1d65584d6bb114
314111mirtazapine 30 MG Oral TabletPSN82a615a0-e74a-49cb-9a57-ffbb3df604d514
314111mirtazapine 30 MG Oral TabletPSNaa05d606-29fd-443e-802b-1d65584d6bb114
311726mirtazapine 45 MG Oral TabletPSN82a615a0-e74a-49cb-9a57-ffbb3df604d514
311726mirtazapine 45 MG Oral TabletPSNaa05d606-29fd-443e-802b-1d65584d6bb114
476809mirtazapine 7.5 MG Oral TabletPSNaa05d606-29fd-443e-802b-1d65584d6bb114
311725mirtazapine 15 MG Oral TabletSCDaa05d606-29fd-443e-802b-1d65584d6bb114
311725mirtazapine 15 MG Oral TabletSCD82a615a0-e74a-49cb-9a57-ffbb3df604d514
314111mirtazapine 30 MG Oral TabletSCD82a615a0-e74a-49cb-9a57-ffbb3df604d514
314111mirtazapine 30 MG Oral TabletSCDaa05d606-29fd-443e-802b-1d65584d6bb114
311726mirtazapine 45 MG Oral TabletSCD82a615a0-e74a-49cb-9a57-ffbb3df604d514
311726mirtazapine 45 MG Oral TabletSCDaa05d606-29fd-443e-802b-1d65584d6bb114
476809mirtazapine 7.5 MG Oral TabletSCDaa05d606-29fd-443e-802b-1d65584d6bb114
311725mirtazapine 15 MG Oral TabletPSNf54718d1-3ef7-4472-9e97-90e5fd30db4d12
311725mirtazapine 15 MG Oral TabletSCDf54718d1-3ef7-4472-9e97-90e5fd30db4d12
311725mirtazapine 15 MG Oral TabletPSN81d9e47e-ae81-4755-a5ee-546a038fadb411
311725mirtazapine 15 MG Oral TabletSCD81d9e47e-ae81-4755-a5ee-546a038fadb411
311725mirtazapine 15 MG Oral TabletPSNbeaa0678-e4b9-4241-8b08-e69e2e49530f9
311725mirtazapine 15 MG Oral TabletSCDbeaa0678-e4b9-4241-8b08-e69e2e49530f9
311725mirtazapine 15 MG Oral TabletPSN758b63b4-904c-4fba-acfc-4d85e3a74c885
311725mirtazapine 15 MG Oral TabletSCD758b63b4-904c-4fba-acfc-4d85e3a74c885
311725mirtazapine 15 MG Oral TabletPSN75dd7e5b-32ec-433b-8379-11cfb372f0d03
314111mirtazapine 30 MG Oral TabletPSN75dd7e5b-32ec-433b-8379-11cfb372f0d03
311726mirtazapine 45 MG Oral TabletPSN75dd7e5b-32ec-433b-8379-11cfb372f0d03
311725mirtazapine 15 MG Oral TabletSCD75dd7e5b-32ec-433b-8379-11cfb372f0d03
314111mirtazapine 30 MG Oral TabletSCD75dd7e5b-32ec-433b-8379-11cfb372f0d03
311726mirtazapine 45 MG Oral TabletSCD75dd7e5b-32ec-433b-8379-11cfb372f0d03
311725mirtazapine 15 MG Oral TabletPSNf8c383c1-d1b3-ceaa-e053-6294a90a60532
311725mirtazapine 15 MG Oral TabletPSN1d6161e3-2e4e-5446-e054-00144ff8d46c2
311725mirtazapine 15 MG Oral TabletSCD1d6161e3-2e4e-5446-e054-00144ff8d46c2
311725mirtazapine 15 MG Oral TabletSCDf8c383c1-d1b3-ceaa-e053-6294a90a60532
311725mirtazapine 15 MG Oral TabletPSN20b2b378-f493-4f57-a5c1-54865d8c01831
311725mirtazapine 15 MG Oral TabletPSN20a724c6-feba-40e7-a35a-8a37de2e01361
311725mirtazapine 15 MG Oral TabletPSN1473011e-7c96-482a-83e8-af339cb0b2741
314111mirtazapine 30 MG Oral TabletPSN20a724c6-feba-40e7-a35a-8a37de2e01361
311725mirtazapine 15 MG Oral TabletSCD20b2b378-f493-4f57-a5c1-54865d8c01831
311725mirtazapine 15 MG Oral TabletSCD20a724c6-feba-40e7-a35a-8a37de2e01361
311725mirtazapine 15 MG Oral TabletSCD1473011e-7c96-482a-83e8-af339cb0b2741
314111mirtazapine 30 MG Oral TabletSCD20a724c6-feba-40e7-a35a-8a37de2e01361

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13107-031-0113107003101100 TABLET, FILM COATED in 1 BOTTLE (13107-031-01) 2009-08-170000-00-00NoNoCurrent
13107-031-0513107003105500 TABLET, FILM COATED in 1 BOTTLE (13107-031-05) 2009-08-170000-00-00NoNoCurrent
13107-031-301310700313030 TABLET, FILM COATED in 1 BOTTLE (13107-031-30) 2009-08-170000-00-00NoNoCurrent
13107-031-321310700313230 TABLET, FILM COATED in 1 BLISTER PACK (13107-031-32) 2009-08-170000-00-00NoNoCurrent
13107-031-341310700313430 TABLET, FILM COATED in 1 BOTTLE (13107-031-34) 2009-08-170000-00-00NoNoCurrent
13107-031-601310700316060 TABLET, FILM COATED in 1 BOTTLE (13107-031-60) 2009-08-170000-00-00NoNoCurrent
13107-031-901310700319090 TABLET, FILM COATED in 1 BOTTLE (13107-031-90) 2009-08-170000-00-00NoNoCurrent