Mirtazapine

Product NDC
55154-5355
11-digit product format
551545355
Labeler code
55154
Product ID
55154-5355_993bb040-7bcd-4d39-8e39-5ee8d1629277
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA076122
Marketing category
ANDA
Marketing start
2009-11-30
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
55154-5355-0Mirtazapine10 in 1 BAGTABLET, FILM COATED1014
55154-5355-0Mirtazapine1 in 1 BLISTER PACKTABLET, FILM COATED114

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET [CARDINAL HEALTH]6
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET [CARDINAL HEALTH]6
AMMONIUM LAURETH-5 SULFATEINACTIVE INGREDIENT43ZIH89I48MIRTAZAPINE TABLET [CARDINAL HEALTH]6
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKMIRTAZAPINE TABLET [CARDINAL HEALTH]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMIRTAZAPINE TABLET [CARDINAL HEALTH]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MIRTAZAPINE TABLET [CARDINAL HEALTH]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKMIRTAZAPINE TABLET [CARDINAL HEALTH]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8MIRTAZAPINE TABLET [CARDINAL HEALTH]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMIRTAZAPINE TABLET [CARDINAL HEALTH]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET [CARDINAL HEALTH]6
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEMIRTAZAPINE TABLET [CARDINAL HEALTH]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET [CARDINAL HEALTH]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMIRTAZAPINE TABLET [CARDINAL HEALTH]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET [CARDINAL HEALTH]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET [CARDINAL HEALTH]6
TRIACETININACTIVE INGREDIENTXHX3C3X673MIRTAZAPINE TABLET [CARDINAL HEALTH]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-5355MIRTAZAPINE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]14Current NDC, Legacy NDC, 2 package rows20250122_89ae6a33-933f-47aa-a2de-2a71cd3f7d44.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN89ae6a33-933f-47aa-a2de-2a71cd3f7d4414
311725mirtazapine 15 MG Oral TabletSCD89ae6a33-933f-47aa-a2de-2a71cd3f7d4414

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-5355-05515453550010 BLISTER PACK in 1 BAG (55154-5355-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2009-11-300000-00-00NoNoCurrent