Mirtazapine

Product NDC
13107-003
11-digit product format
131070003
Labeler code
13107
Product ID
13107-003_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
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
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
13107-003-01Mirtazapine100 in 1 BOTTLETABLET, FILM COATED10014
13107-003-05Mirtazapine500 in 1 BOTTLETABLET, FILM COATED50014
13107-003-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3014
13107-003-32Mirtazapine30 in 1 BLISTER PACKTABLET, FILM COATED3014
13107-003-34Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3014
13107-003-60Mirtazapine60 in 1 BOTTLETABLET, FILM COATED6014
13107-003-90Mirtazapine90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-003-05EA - Each13107-003832bfc37-c29d-4c43-a387-b5d7c455dc8d12012-07-24
13107-003-30EA - Each13107-0032552ef70-db37-48c3-a1b5-394b0f69e4c012012-07-24
13107-003-34EA - Each13107-003d72f67a3-cfc1-4786-aeee-7fc2f1d11a1312012-07-24

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 INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MirtazapineACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
MirtazapineACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MirtazapineACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
MirtazapineACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]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 (TYPE H)INACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]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
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]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
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [TYA PHARMACEUTICALS]2
MirtazapineACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
MirtazapineACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-003MIRTAZAPINE 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 TabletPSNaa05d606-29fd-443e-802b-1d65584d6bb114
311725mirtazapine 15 MG Oral TabletPSN82a615a0-e74a-49cb-9a57-ffbb3df604d514
314111mirtazapine 30 MG Oral TabletPSNaa05d606-29fd-443e-802b-1d65584d6bb114
314111mirtazapine 30 MG Oral TabletPSN82a615a0-e74a-49cb-9a57-ffbb3df604d514
311726mirtazapine 45 MG Oral TabletPSNaa05d606-29fd-443e-802b-1d65584d6bb114
311726mirtazapine 45 MG Oral TabletPSN82a615a0-e74a-49cb-9a57-ffbb3df604d514
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 TabletSCDaa05d606-29fd-443e-802b-1d65584d6bb114
314111mirtazapine 30 MG Oral TabletSCD82a615a0-e74a-49cb-9a57-ffbb3df604d514
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 TabletPSN75dd7e5b-32ec-433b-8379-11cfb372f0d03
314111mirtazapine 30 MG Oral TabletPSNa96e0d95-1a7b-4588-923a-2169b55062033
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 TabletSCDa96e0d95-1a7b-4588-923a-2169b55062033
314111mirtazapine 30 MG Oral TabletSCD75dd7e5b-32ec-433b-8379-11cfb372f0d03
311726mirtazapine 45 MG Oral TabletSCD75dd7e5b-32ec-433b-8379-11cfb372f0d03
314111mirtazapine 30 MG Oral TabletPSN18a9c172-7081-484a-8c3b-bde9b2e54e952
314111mirtazapine 30 MG Oral TabletPSN411e4665-cdca-4af3-9708-2c978680b91b2
314111mirtazapine 30 MG Oral TabletSCD18a9c172-7081-484a-8c3b-bde9b2e54e952
314111mirtazapine 30 MG Oral TabletSCD411e4665-cdca-4af3-9708-2c978680b91b2
311725mirtazapine 15 MG Oral TabletPSN20a724c6-feba-40e7-a35a-8a37de2e01361
314111mirtazapine 30 MG Oral TabletPSN74a3f517-63eb-4e33-b75f-ef59ce14c1c81
314111mirtazapine 30 MG Oral TabletPSNedc62571-3808-b4b4-e053-2a95a90ab4361
314111mirtazapine 30 MG Oral TabletPSN5aa52c22-f6b8-421c-e053-2991aa0aaf461
314111mirtazapine 30 MG Oral TabletPSNa8f3b8c4-1d16-93c9-e053-2a95a90aa3771
314111mirtazapine 30 MG Oral TabletPSN54cef7d4-99d5-4863-a4fe-48e535b20f661
314111mirtazapine 30 MG Oral TabletPSN51269807-2b5a-e7aa-e063-6394a90ab6571
314111mirtazapine 30 MG Oral TabletPSN20a724c6-feba-40e7-a35a-8a37de2e01361
311726mirtazapine 45 MG Oral TabletPSN5aa52c22-f6b8-421c-e053-2991aa0aaf461
311725mirtazapine 15 MG Oral TabletSCD20a724c6-feba-40e7-a35a-8a37de2e01361
314111mirtazapine 30 MG Oral TabletSCDedc62571-3808-b4b4-e053-2a95a90ab4361
314111mirtazapine 30 MG Oral TabletSCD20a724c6-feba-40e7-a35a-8a37de2e01361
314111mirtazapine 30 MG Oral TabletSCD51269807-2b5a-e7aa-e063-6394a90ab6571
314111mirtazapine 30 MG Oral TabletSCDa8f3b8c4-1d16-93c9-e053-2a95a90aa3771
314111mirtazapine 30 MG Oral TabletSCD54cef7d4-99d5-4863-a4fe-48e535b20f661
314111mirtazapine 30 MG Oral TabletSCD5aa52c22-f6b8-421c-e053-2991aa0aaf461
314111mirtazapine 30 MG Oral TabletSCD74a3f517-63eb-4e33-b75f-ef59ce14c1c81
311726mirtazapine 45 MG Oral TabletSCD5aa52c22-f6b8-421c-e053-2991aa0aaf461

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13107-003-0113107000301100 TABLET, FILM COATED in 1 BOTTLE (13107-003-01) 2009-08-170000-00-00NoNoCurrent
13107-003-0513107000305500 TABLET, FILM COATED in 1 BOTTLE (13107-003-05) 2009-08-170000-00-00NoNoCurrent
13107-003-301310700033030 TABLET, FILM COATED in 1 BOTTLE (13107-003-30) 2009-08-170000-00-00NoNoCurrent
13107-003-321310700033230 TABLET, FILM COATED in 1 BLISTER PACK (13107-003-32) 2009-08-170000-00-00NoNoCurrent
13107-003-341310700033430 TABLET, FILM COATED in 1 BOTTLE (13107-003-34) 2009-08-170000-00-00NoNoCurrent
13107-003-601310700036060 TABLET, FILM COATED in 1 BOTTLE (13107-003-60) 2009-08-170000-00-00NoNoCurrent
13107-003-901310700039090 TABLET, FILM COATED in 1 BOTTLE (13107-003-90) 2009-08-170000-00-00NoNoCurrent