FDA.reportPublic FDA data

Mirtazapine

Product NDC
50090-2558
11-digit product format
500902558
Labeler code
50090
Product ID
50090-2558_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
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
50090-2558-0Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3027
50090-2558-2Mirtazapine60 in 1 BOTTLETABLET, FILM COATED6027
50090-2558-3Mirtazapine90 in 1 BOTTLETABLET, FILM COATED9027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2558-0EA - Each50090-25585b9f9a1a-7cc7-4627-ace4-a5f0b7fe3e5112024-03-12
50090-2558-2EA - Each50090-2558b98f02c5-dc36-47d5-97cf-3f7f83f5fd4112019-04-11
50090-2558-3EA - Each50090-255874bed244-d26d-40c2-a77c-d3fac316ddf112019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2558MIRTAZAPINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]25Current NDC, Legacy NDC, 3 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
50090-2558-05009025580030 TABLET, FILM COATED in 1 BOTTLE (50090-2558-0) 2017-03-130000-00-00NoNoCurrent
50090-2558-25009025580260 TABLET, FILM COATED in 1 BOTTLE (50090-2558-2) 2016-12-160000-00-00NoNoCurrent
50090-2558-35009025580390 TABLET, FILM COATED in 1 BOTTLE (50090-2558-3) 2016-10-250000-00-00NoNoCurrent