Mirtazapine

Product NDC
71335-2471
11-digit product format
713352471
Labeler code
71335
Product ID
71335-2471_bd4173ae-2a8b-432f-ac5c-263cddbef930
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205798
Marketing category
ANDA
Marketing start
2022-08-07
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
Rxcui283407

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
71335-2471-1Mirtazapine30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING30100

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2471MIRTAZAPINE TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20241115_c47428e5-4717-4471-9231-ec8b5438205a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283407mirtazapine 30 MG Disintegrating Oral TabletPSNc47428e5-4717-4471-9231-ec8b5438205a100
283407mirtazapine 30 MG Disintegrating Oral TabletSCDc47428e5-4717-4471-9231-ec8b5438205a100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2471-17133524710130 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-2471-1) 2024-11-13NoNoHistorical