FDA.reportPublic FDA data

Mirtazapine

Product NDC
71610-100
11-digit product format
716100100
Labeler code
71610
Product ID
71610-100_b5d04e06-e889-4ccd-97eb-967ec6e00a6c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA076921
Marketing category
ANDA
Marketing start
2004-10-22
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
71610-100-15Mirtazapine15 in 1 BOTTLETABLET, FILM COATED151
71610-100-45Mirtazapine45 in 1 BOTTLETABLET, FILM COATED451
71610-100-53Mirtazapine60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-100-15EA - Each71610-1009112c766-bbdf-4e0e-8406-76d5b88d89cd12018-10-11
71610-100-45EA - Each71610-1001744d275-45c8-4cf8-b2a7-848766668b7312018-10-11
71610-100-53EA - Each71610-100e9984b7a-3230-4007-bd13-4e78305c826a12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-100MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 3 package rows20180816_6ad0e695-92ee-4900-b194-a2455473370b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314111mirtazapine 30 MG Oral TabletPSN6ad0e695-92ee-4900-b194-a2455473370b1
314111mirtazapine 30 MG Oral TabletSCD6ad0e695-92ee-4900-b194-a2455473370b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-100-157161001001515 TABLET, FILM COATED in 1 BOTTLE (71610-100-15) 2018-07-200000-00-00NoNoCurrent
71610-100-457161001004545 TABLET, FILM COATED in 1 BOTTLE (71610-100-45) 2018-07-200000-00-00NoNoCurrent
71610-100-537161001005360 TABLET, FILM COATED in 1 BOTTLE (71610-100-53) 2018-07-200000-00-00NoNoCurrent