FDA.reportPublic FDA data

Mirtazapine

Product NDC
70518-2819
11-digit product format
705182819
Labeler code
70518
Product ID
70518-2819_4ab63e12-0986-52a7-e063-6294a90a549c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076921
Marketing category
ANDA
Marketing start
2020-07-23
Substance
MIRTAZAPINE
Active strength
7.5 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
MIRTAZAPINE7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui476809

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1ca5a24a-fafa-8fc8-52ac-b403ff18faa5Product name320240216
a733d273-402b-1005-9891-1ac1a9c63703Product name220170724

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2819-02022-02-04C16284748780-1d6a99b39-5fcd-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
70518-2819-02022-02-04C16284748780-1d6a99b39-5fcd-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
70518-2819-02022-01-28C16284748780-1d6a99b39-5fcd-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996
70518-2819-02022-01-28C16284748780-1d6a99b39-5fcd-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use MIRTAZAPINE TABLETS safely and effectively. See full prescribing information for MIRTAZAPINE TABLETS. MIRTAZAPINE tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2819-0Mirtazapine30 in 1 BOXTABLET, FILM COATED3010
70518-2819-1Mirtazapine1 in 1 POUCHTABLET, FILM COATED110
70518-2819-2Mirtazapine30 in 1 BLISTER PACKTABLET, FILM COATED3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2819MIRTAZAPINE TABLET, FILM COATED [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 3 package rows20250403_10ea9d83-19c3-4f3b-a1cc-cfc48b42507f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476809mirtazapine 7.5 MG Oral TabletPSN10ea9d83-19c3-4f3b-a1cc-cfc48b42507f10
476809mirtazapine 7.5 MG Oral TabletSCD10ea9d83-19c3-4f3b-a1cc-cfc48b42507f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2819-07051828190030 POUCH in 1 BOX (70518-2819-0) > 1 TABLET, FILM COATED in 1 POUCH (70518-2819-1) 30 pouch2020-07-230000-00-00NoNoCurrent
70518-2819-1705182819011 in 1 POUCHHistorical
70518-2819-27051828190230 TABLET, FILM COATED in 1 BLISTER PACK (70518-2819-2) 2023-07-12NoNoHistorical