FDA.reportPublic FDA data

Mirtazapine

Product NDC
57237-010
11-digit product format
572370010
Labeler code
57237
Product ID
57237-010_7616f3f3-c42e-474d-b201-0235120cff36
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
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
57237-010-05Mirtazapine500 in 1 BOTTLETABLET, FILM COATED50015
57237-010-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-010-05EA - Each57237-0106c4fc8da-d927-45de-a934-0077f834bfd712014-04-03
57237-010-30EA - Each57237-0109a31a55a-cf77-4ff4-b94a-3bc2908dd4fb12014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]2
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTMIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-010MIRTAZAPINE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]14Current NDC, Legacy NDC, 2 package rows20240203_58e9b4c6-531f-49c4-a640-6953e70892fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311726mirtazapine 45 MG Oral TabletPSN7727fe84-f6cc-4b31-bc00-1ecf741ad361104
311726mirtazapine 45 MG Oral TabletSCD7727fe84-f6cc-4b31-bc00-1ecf741ad361104
311725mirtazapine 15 MG Oral TabletPSN58e9b4c6-531f-49c4-a640-6953e70892fe15
314111mirtazapine 30 MG Oral TabletPSN58e9b4c6-531f-49c4-a640-6953e70892fe15
311726mirtazapine 45 MG Oral TabletPSN58e9b4c6-531f-49c4-a640-6953e70892fe15
476809mirtazapine 7.5 MG Oral TabletPSN58e9b4c6-531f-49c4-a640-6953e70892fe15
311725mirtazapine 15 MG Oral TabletSCD58e9b4c6-531f-49c4-a640-6953e70892fe15
314111mirtazapine 30 MG Oral TabletSCD58e9b4c6-531f-49c4-a640-6953e70892fe15
311726mirtazapine 45 MG Oral TabletSCD58e9b4c6-531f-49c4-a640-6953e70892fe15
476809mirtazapine 7.5 MG Oral TabletSCD58e9b4c6-531f-49c4-a640-6953e70892fe15
311726mirtazapine 45 MG Oral TabletPSN1b13d7ec-ecdc-482c-8fe2-b999bab3bbeb9
311726mirtazapine 45 MG Oral TabletSCD1b13d7ec-ecdc-482c-8fe2-b999bab3bbeb9
311726mirtazapine 45 MG Oral TabletPSN3d63f74b-8069-45f7-9cf6-10b8ad628ff03
311726mirtazapine 45 MG Oral TabletSCD3d63f74b-8069-45f7-9cf6-10b8ad628ff03
311726mirtazapine 45 MG Oral TabletPSN2a0689ae-5650-42d1-ac9d-56dd2b4677272
311726mirtazapine 45 MG Oral TabletSCD2a0689ae-5650-42d1-ac9d-56dd2b4677272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-010-0557237001005500 TABLET, FILM COATED in 1 BOTTLE (57237-010-05) 2004-10-220000-00-00NoNoCurrent
57237-010-305723700103030 TABLET, FILM COATED in 1 BOTTLE (57237-010-30) 2004-10-220000-00-00NoNoCurrent