Mirtazapine

Product NDC
70518-0180
11-digit product format
705180180
Labeler code
70518
Product ID
70518-0180_47e46668-d67d-0d37-e063-6394a90a7dc4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076921
Marketing category
ANDA
Marketing start
2017-01-26
Substance
MIRTAZAPINE
Active strength
15 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
MIRTAZAPINE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui311725

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
70518-0180-0Mirtazapine30 in 1 BLISTER PACKTABLET, FILM COATED3015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0180MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 1 package rows20250424_d1b59d87-8442-4c15-8bb9-e39b198d8677.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSNd1b59d87-8442-4c15-8bb9-e39b198d867715
311725mirtazapine 15 MG Oral TabletSCDd1b59d87-8442-4c15-8bb9-e39b198d867715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-0180-07051801800030 TABLET, FILM COATED in 1 BLISTER PACK (70518-0180-0) 2017-01-26NoNoCurrent