FDA.reportPublic FDA data

Mirtazapine

Product NDC
13107-001
11-digit product format
131070001
Labeler code
13107
Product ID
13107-001_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
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
13107-001-01Mirtazapine100 in 1 BOTTLETABLET, FILM COATED10014
13107-001-05Mirtazapine500 in 1 BOTTLETABLET, FILM COATED50014
13107-001-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3014
13107-001-60Mirtazapine60 in 1 BOTTLETABLET, FILM COATED6014
13107-001-90Mirtazapine90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-001-05EA - Each13107-00145a32c21-e565-4a76-ad48-ad95d1fa7ae012014-01-04
13107-001-30EA - Each13107-001aa8a9001-6846-43f8-b9bd-6255f988db9d12014-01-04

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-001MIRTAZAPINE TABLET, FILM COATED [AUROLIFE PHARMA LLC]13Current NDC, Legacy NDC, 5 package rows20240126_aa05d606-29fd-443e-802b-1d65584d6bb1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476809mirtazapine 7.5 MG Oral TabletPSNbd532a25-cfde-4c7d-8015-ba40609fb95c103
476809mirtazapine 7.5 MG Oral TabletSCDbd532a25-cfde-4c7d-8015-ba40609fb95c103
476809mirtazapine 7.5 MG Oral TabletPSNc2b38cc5-7738-44fa-9bef-89a18a1039b2100
476809mirtazapine 7.5 MG Oral TabletPSN55c5905c-6cb8-4ed4-8e69-97f733ca91b5100
476809mirtazapine 7.5 MG Oral TabletSCDc2b38cc5-7738-44fa-9bef-89a18a1039b2100
476809mirtazapine 7.5 MG Oral TabletSCD55c5905c-6cb8-4ed4-8e69-97f733ca91b5100
311725mirtazapine 15 MG Oral TabletPSNaa05d606-29fd-443e-802b-1d65584d6bb114
314111mirtazapine 30 MG Oral TabletPSNaa05d606-29fd-443e-802b-1d65584d6bb114
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
314111mirtazapine 30 MG Oral TabletSCDaa05d606-29fd-443e-802b-1d65584d6bb114
311726mirtazapine 45 MG Oral TabletSCDaa05d606-29fd-443e-802b-1d65584d6bb114
476809mirtazapine 7.5 MG Oral TabletSCDaa05d606-29fd-443e-802b-1d65584d6bb114
476809mirtazapine 7.5 MG Oral TabletPSN3b7a5f44-8da6-4196-bb5d-8d2770af1b3a5
476809mirtazapine 7.5 MG Oral TabletSCD3b7a5f44-8da6-4196-bb5d-8d2770af1b3a5
476809mirtazapine 7.5 MG Oral TabletPSNe6e5cbf7-a958-4ef8-abcc-a7491edb95204
476809mirtazapine 7.5 MG Oral TabletSCDe6e5cbf7-a958-4ef8-abcc-a7491edb95204
476809mirtazapine 7.5 MG Oral TabletPSN2990e296-2d66-70c0-e063-6394a90abbe41
476809mirtazapine 7.5 MG Oral TabletSCD2990e296-2d66-70c0-e063-6394a90abbe41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13107-001-0113107000101100 TABLET, FILM COATED in 1 BOTTLE (13107-001-01) 2009-08-170000-00-00NoNoCurrent
13107-001-0513107000105500 TABLET, FILM COATED in 1 BOTTLE (13107-001-05) 2009-08-170000-00-00NoNoCurrent
13107-001-301310700013030 TABLET, FILM COATED in 1 BOTTLE (13107-001-30) 2009-08-170000-00-00NoNoCurrent
13107-001-601310700016060 TABLET, FILM COATED in 1 BOTTLE (13107-001-60) 2009-08-170000-00-00NoNoCurrent
13107-001-901310700019090 TABLET, FILM COATED in 1 BOTTLE (13107-001-90) 2009-08-170000-00-00NoNoCurrent