FDA.reportPublic FDA data

Mirtazapine

Product NDC
68788-8459
11-digit product format
687888459
Labeler code
68788
Product ID
68788-8459_36a45881-20c0-4364-b413-98d54eb1909f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA076921
Marketing category
ANDA
Marketing start
2023-06-14
Substance
MIRTAZAPINE
Active strength
45 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
MIRTAZAPINE45 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui311726

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
68788-8459-3Mirtazapine30 in 1 BOTTLETABLET, FILM COATED302
68788-8459-6Mirtazapine60 in 1 BOTTLETABLET, FILM COATED602
68788-8459-9Mirtazapine90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8459-3EA - Each68788-8459cc869676-8d12-4b65-a1a6-b37b760e46a812023-07-06
68788-8459-6EA - Each68788-8459f2aa33db-c33b-44d3-8013-93b1e5f814f512023-07-06
68788-8459-9EA - Each68788-8459fed416b6-592f-40ba-8433-dbd97b1f973f12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8459MIRTAZAPINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 3 package rows20250117_2a0689ae-5650-42d1-ac9d-56dd2b467727.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311726mirtazapine 45 MG Oral TabletPSN2a0689ae-5650-42d1-ac9d-56dd2b4677272
311726mirtazapine 45 MG Oral TabletSCD2a0689ae-5650-42d1-ac9d-56dd2b4677272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8459-36878884590330 TABLET, FILM COATED in 1 BOTTLE (68788-8459-3) 2023-06-14NoNoHistorical
68788-8459-66878884590660 TABLET, FILM COATED in 1 BOTTLE (68788-8459-6) 2023-06-14NoNoHistorical
68788-8459-96878884590990 TABLET, FILM COATED in 1 BOTTLE (68788-8459-9) 2023-06-14NoNoHistorical