FDA.reportPublic FDA data

Mirtazapine

Product NDC
57237-009
11-digit product format
572370009
Labeler code
57237
Product ID
57237-009_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
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
57237-009-05Mirtazapine500 in 1 BOTTLETABLET, FILM COATED50015
57237-009-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-009-05EA - Each57237-00953672cab-b040-48fe-a813-08fa6aa4a7c212014-04-03
57237-009-30EA - Each57237-009ee8d43c9-5846-4f9a-9009-8740d019f17912014-04-03

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
57237-009MIRTAZAPINE 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
311725mirtazapine 15 MG Oral TabletPSN552e2261-53db-4a27-b277-f7b62c3ea2ed27
314111mirtazapine 30 MG Oral TabletPSN552e2261-53db-4a27-b277-f7b62c3ea2ed27
311725mirtazapine 15 MG Oral TabletSCD552e2261-53db-4a27-b277-f7b62c3ea2ed27
314111mirtazapine 30 MG Oral TabletSCD552e2261-53db-4a27-b277-f7b62c3ea2ed27
314111mirtazapine 30 MG Oral TabletPSNaae4c58a-5cbd-45ef-b0f9-32bf28204f1518
314111mirtazapine 30 MG Oral TabletSCDaae4c58a-5cbd-45ef-b0f9-32bf28204f1518
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
314111mirtazapine 30 MG Oral TabletPSN1fb26f9b-b075-471d-8cc3-fa39246ec2e411
314111mirtazapine 30 MG Oral TabletSCD1fb26f9b-b075-471d-8cc3-fa39246ec2e411
314111mirtazapine 30 MG Oral TabletPSNac3716fd-6971-4a70-ae7b-9f5117f3d8806
314111mirtazapine 30 MG Oral TabletSCDac3716fd-6971-4a70-ae7b-9f5117f3d8806
314111mirtazapine 30 MG Oral TabletPSN8e839bb2-2f67-f224-e053-2a95a90ae5d83
314111mirtazapine 30 MG Oral TabletPSN1cc15904-4339-4816-ba1f-ad276f3f52093
314111mirtazapine 30 MG Oral TabletSCD1cc15904-4339-4816-ba1f-ad276f3f52093
314111mirtazapine 30 MG Oral TabletSCD8e839bb2-2f67-f224-e053-2a95a90ae5d83
314111mirtazapine 30 MG Oral TabletPSN6ad0e695-92ee-4900-b194-a2455473370b1
314111mirtazapine 30 MG Oral TabletPSN50718832-88fb-dec1-e063-6294a90ae4681
314111mirtazapine 30 MG Oral TabletPSN3699b988-6d9a-dcc1-e063-6394a90ab38d1
314111mirtazapine 30 MG Oral TabletPSNd6fbe837-988a-7c75-e053-2995a90a599a1
314111mirtazapine 30 MG Oral TabletSCD6ad0e695-92ee-4900-b194-a2455473370b1
314111mirtazapine 30 MG Oral TabletSCD50718832-88fb-dec1-e063-6294a90ae4681
314111mirtazapine 30 MG Oral TabletSCD3699b988-6d9a-dcc1-e063-6394a90ab38d1
314111mirtazapine 30 MG Oral TabletSCDd6fbe837-988a-7c75-e053-2995a90a599a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-009-0557237000905500 TABLET, FILM COATED in 1 BOTTLE (57237-009-05) 2004-10-220000-00-00NoNoCurrent
57237-009-305723700093030 TABLET, FILM COATED in 1 BOTTLE (57237-009-30) 2004-10-220000-00-00NoNoCurrent