Mirtazapine

Product NDC
63629-2366
11-digit product format
636292366
Labeler code
63629
Product ID
63629-2366_956003b0-938c-4a53-9766-d2a86abefaa3
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
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
63629-2366-1Mirtazapine1000 in 1 BOTTLETABLET1000106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2366-1EA - Each63629-2366f511aeaa-8594-4947-a3f1-c8b4d3a4329412021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2366MIRTAZAPINE TABLET [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20240913_8c03eb2b-6aed-40a1-a424-67ac1ab6085d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN8c03eb2b-6aed-40a1-a424-67ac1ab6085d106
311725mirtazapine 15 MG Oral TabletSCD8c03eb2b-6aed-40a1-a424-67ac1ab6085d106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2366-1636292366011000 TABLET in 1 BOTTLE (63629-2366-1) 1000 tablet2017-04-220000-00-00NoNoCurrent