Mirtazapine

Product NDC
63629-2368
11-digit product format
636292368
Labeler code
63629
Product ID
63629-2368_3204d175-0c96-44c1-8487-c8cddede729b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076541
Marketing category
ANDA
Marketing start
2004-04-22
Substance
MIRTAZAPINE
Active strength
30 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
MIRTAZAPINE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui314111

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
63629-2368-1Mirtazapine30 in 1 BOTTLETABLET30106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2368MIRTAZAPINE TABLET [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20241128_3bb242b0-42ed-471a-b3c4-5ded1e292e80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314111mirtazapine 30 MG Oral TabletPSN3bb242b0-42ed-471a-b3c4-5ded1e292e80106
314111mirtazapine 30 MG Oral TabletSCD3bb242b0-42ed-471a-b3c4-5ded1e292e80106
314111mirtazapine 30 MG Oral TabletPSN50ccc34a-4b89-4b07-b153-6c71c6924db11
314111mirtazapine 30 MG Oral TabletSCD50ccc34a-4b89-4b07-b153-6c71c6924db11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2368-16362923680130 TABLET in 1 BOTTLE (63629-2368-1) 30 tablet2004-04-220000-00-00NoNoCurrent