FDA.reportPublic FDA data

Mirtazapine

Product NDC
71610-846
11-digit product format
716100846
Labeler code
71610
Product ID
71610-846_1dffd745-a863-1f0e-e063-6394a90a1fff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA216751
Marketing category
ANDA
Marketing start
2023-09-01
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
71610-846-15Mirtazapine15 in 1 BOTTLETABLET, FILM COATED151
71610-846-30Mirtazapine30 in 1 BOTTLETABLET, FILM COATED301
71610-846-45Mirtazapine45 in 1 BOTTLETABLET, FILM COATED451
71610-846-53Mirtazapine60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-846-15EA - Each71610-846bf4c27af-0aac-4e01-9702-849cc24147f612024-09-09
71610-846-30EA - Each71610-8468a85f1ae-b569-4c1f-86aa-26a37b4f507812024-09-09
71610-846-45EA - Each71610-846688cbf7a-b23f-4093-ba75-5dd44bcfb74012024-09-09
71610-846-53EA - Each71610-8467fe6514b-37ff-4a0c-8592-1f7c51515bac12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-846MIRTAZAPINE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]1Current NDC, 4 package rows20240725_1e0006b6-9405-95a7-e063-6294a90aa277.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314111mirtazapine 30 MG Oral TabletPSN1e0006b6-9405-95a7-e063-6294a90aa2771
314111mirtazapine 30 MG Oral TabletSCD1e0006b6-9405-95a7-e063-6294a90aa2771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-846-157161008461515 TABLET, FILM COATED in 1 BOTTLE (71610-846-15) 2024-07-17NoNoHistorical
71610-846-307161008463030 TABLET, FILM COATED in 1 BOTTLE (71610-846-30) 2024-07-17NoNoHistorical
71610-846-457161008464545 TABLET, FILM COATED in 1 BOTTLE (71610-846-45) 2024-07-17NoNoHistorical
71610-846-537161008465360 TABLET, FILM COATED in 1 BOTTLE (71610-846-53) 2024-07-17NoNoHistorical