Mirtazapine

Product NDC
70518-2581
11-digit product format
705182581
Labeler code
70518
Product ID
70518-2581_4a68f004-3827-fb70-e063-6394a90a1728
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076921
Marketing category
ANDA
Marketing start
2020-02-16
Substance
MIRTAZAPINE
Active strength
45 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
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
70518-2581-0Mirtazapine30 in 1 BLISTER PACKTABLET, FILM COATED309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2581MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 1 package rows20250321_1b13d7ec-ecdc-482c-8fe2-b999bab3bbeb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311726mirtazapine 45 MG Oral TabletPSN1b13d7ec-ecdc-482c-8fe2-b999bab3bbeb9
311726mirtazapine 45 MG Oral TabletSCD1b13d7ec-ecdc-482c-8fe2-b999bab3bbeb9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2581-07051825810030 TABLET, FILM COATED in 1 BLISTER PACK (70518-2581-0) 2020-02-160000-00-00NoNoCurrent