FDA.reportPublic FDA data

Mirtazapine

Product NDC
61919-153
11-digit product format
619190153
Labeler code
61919
Product ID
61919-153_47e14699-4104-6433-e063-6394a90acbcc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA077666
Marketing category
ANDA
Marketing start
2022-05-10
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-153-302020-01-31C16284748780-19d75b9d1-294c-f424-e053-dadaa90a57ceMIRTAZAPINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-153-60Mirtazapine60 in 1 BOTTLETABLET, FILM COATED603
61919-153-30MIRTAZAPINE30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-153MIRTAZAPINE TABLET, FILM COATED [DIRECT_RX]2Current NDC, Legacy NDC, 1 package rows20240110_dea8c09a-b759-1da7-e053-2a95a90a3346.zip
61919-153MIRTAZAPINE TABLET, FILM COATED [DIRECTRX]1Current NDC, Legacy NDC, 1 package rows20151028_3000c647-d052-4ebd-a809-39a4a514842d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSNdea8c09a-b759-1da7-e053-2a95a90a33463
311725mirtazapine 15 MG Oral TabletSCDdea8c09a-b759-1da7-e053-2a95a90a33463
311725mirtazapine 15 MG Oral TabletPSN3000c647-d052-4ebd-a809-39a4a514842d1
311725mirtazapine 15 MG Oral TabletSCD3000c647-d052-4ebd-a809-39a4a514842d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-153-306191901533030 in 1 BOTTLEHistorical
61919-153-606191901536060 TABLET, FILM COATED in 1 BOTTLE (61919-153-60) 2022-05-100000-00-00NoNoCurrent