Mirtazapine

Product NDC
71335-2412
11-digit product format
713352412
Labeler code
71335
Product ID
71335-2412_661491d5-5639-41ba-a627-8fc3d3ed1c0a
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
2004-10-22
Substance
MIRTAZAPINE
Active strength
7.5 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mirtazapine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRTAZAPINE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui476809

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
71335-2412-1Mirtazapine30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2412-1EA - Each71335-2412dad42767-95fc-46d0-b86e-36097bf385fa12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2412MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]1Current NDC, 1 package rows20240612_6b6e946c-54b5-40e3-918f-9cc29f04cd9a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476809mirtazapine 7.5 MG Oral TabletPSN6b6e946c-54b5-40e3-918f-9cc29f04cd9a2
476809mirtazapine 7.5 MG Oral TabletSCD6b6e946c-54b5-40e3-918f-9cc29f04cd9a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2412-17133524120130 TABLET, FILM COATED in 1 BOTTLE (71335-2412-1) 2024-06-10NoNoCurrent