Mirtazapine

Product NDC
55154-7297
11-digit product format
551547297
Labeler code
55154
Product ID
55154-7297_4ab869fb-4398-4ec0-8e8e-d0a8b6a8314e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA077666
Marketing category
ANDA
Marketing start
2007-08-22
Substance
MIRTAZAPINE
Active strength
15 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
MIRTAZAPINE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui311725

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
55154-7297-0Mirtazapine10 in 1 BAGTABLET, FILM COATED107
55154-7297-0Mirtazapine1 in 1 BLISTER PACKTABLET, FILM COATED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7297MIRTAZAPINE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]6Current NDC, Legacy NDC, 2 package rows20240616_df06ea51-a962-49d0-a449-137e2220ce7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSNdf06ea51-a962-49d0-a449-137e2220ce7e7
311725mirtazapine 15 MG Oral TabletSCDdf06ea51-a962-49d0-a449-137e2220ce7e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-7297-05515472970010 BLISTER PACK in 1 BAG (55154-7297-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2007-08-220000-00-00NoNoCurrent