Mirtazapine

Product NDC
50090-2800
11-digit product format
500902800
Labeler code
50090
Product ID
50090-2800_1227fedd-ff4c-4393-aa32-73ad0b8424b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA076921
Marketing category
ANDA
Marketing start
2004-10-22
Substance
MIRTAZAPINE
Active strength
15 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
MIRTAZAPINE15 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
50090-2800-0Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3027
50090-2800-1Mirtazapine90 in 1 BOTTLETABLET, FILM COATED9027

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2800MIRTAZAPINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]25Current NDC, Legacy NDC, 2 package rows20231211_552e2261-53db-4a27-b277-f7b62c3ea2ed.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2800-05009028000030 TABLET, FILM COATED in 1 BOTTLE (50090-2800-0) 2017-03-020000-00-00NoNoCurrent
50090-2800-15009028000190 TABLET, FILM COATED in 1 BOTTLE (50090-2800-1) 2017-01-190000-00-00NoNoCurrent