Mirtazapine

Product NDC
50090-1058
11-digit product format
500901058
Labeler code
50090
Product ID
50090-1058_eb2f9480-9478-4e6e-99c7-f48bfe8b0bee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077666
Marketing category
ANDA
Marketing start
2007-08-22
Substance
MIRTAZAPINE
Active strength
30 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mirtazapine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRTAZAPINE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui311725, 314111

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
50090-1058-0Mirtazapine30 in 1 BOTTLETABLET, FILM COATED309
50090-1058-2Mirtazapine60 in 1 BOTTLETABLET, FILM COATED609
50090-1058-3Mirtazapine90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1058-0EA - Each50090-1058d2e26f35-df94-4ea8-8832-f648053d0cf712018-11-06
50090-1058-2EA - Each50090-10586e1de7a7-ddb8-4c75-bd31-317fa43df27c12018-11-06
50090-1058-3EA - Each50090-105894a09e94-2904-4324-9186-4527310d8f1e12018-11-06

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN44779383-3ddb-41df-8766-da5d7bef385e9
314111mirtazapine 30 MG Oral TabletPSN44779383-3ddb-41df-8766-da5d7bef385e9
311725mirtazapine 15 MG Oral TabletSCD44779383-3ddb-41df-8766-da5d7bef385e9
314111mirtazapine 30 MG Oral TabletSCD44779383-3ddb-41df-8766-da5d7bef385e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-1058-05009010580030 TABLET, FILM COATED in 1 BOTTLE (50090-1058-0) 2014-11-28NoNoHistorical
50090-1058-25009010580260 TABLET, FILM COATED in 1 BOTTLE (50090-1058-2) 2014-11-28NoNoHistorical
50090-1058-35009010580390 TABLET, FILM COATED in 1 BOTTLE (50090-1058-3) 2014-11-28NoNoHistorical