FDA.reportPublic FDA data

Mirtazapine

Product NDC
63629-3346
11-digit product format
636293346
Labeler code
63629
Product ID
63629-3346_1442b48d-d03d-40ee-a846-e8bc71c3f121
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076921
Marketing category
ANDA
Marketing start
2009-08-17
Substance
MIRTAZAPINE
Active strength
45 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
MIRTAZAPINE45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui311726

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
63629-3346-1Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3015
63629-3346-2Mirtazapine90 in 1 BOTTLETABLET, FILM COATED9015
63629-3346-3Mirtazapine60 in 1 BOTTLETABLET, FILM COATED6015
63629-3346-4Mirtazapine28 in 1 BOTTLETABLET, FILM COATED2815

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3346-1EA - Each63629-334690521302-b450-4d1b-992d-bf4dd5969e9512012-07-24
63629-3346-2EA - Each63629-3346004744f6-032a-4dc2-bdea-1904b85e0ca212015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MIRTAZAPINEACTIVE INGREDIENTA051Q2099QMIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
MIRTAZAPINEACTIVE MOIETYA051Q2099QMIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PMIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-3346MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]14Current NDC, Legacy NDC, 4 package rows20240524_d0cda063-00c5-0921-ee39-d4de1381f91a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311726mirtazapine 45 MG Oral TabletPSNd0cda063-00c5-0921-ee39-d4de1381f91a15
311726mirtazapine 45 MG Oral TabletSCDd0cda063-00c5-0921-ee39-d4de1381f91a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-3346-16362933460130 TABLET, FILM COATED in 1 BOTTLE (63629-3346-1) 2010-01-270000-00-00NoNoCurrent
63629-3346-26362933460290 TABLET, FILM COATED in 1 BOTTLE (63629-3346-2) 2014-03-070000-00-00NoNoCurrent
63629-3346-36362933460360 TABLET, FILM COATED in 1 BOTTLE (63629-3346-3) 2022-03-080000-00-00NoNoCurrent
63629-3346-46362933460428 TABLET, FILM COATED in 1 BOTTLE (63629-3346-4) 2022-03-080000-00-00NoNoCurrent