FDA.reportPublic FDA data

Mirtazapine

Product NDC
71335-0964
11-digit product format
713350964
Labeler code
71335
Product ID
71335-0964_956bdf1e-236a-4ebe-ac0c-f035adf4b4bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076921
Marketing category
ANDA
Marketing start
2004-10-22
Substance
MIRTAZAPINE
Active strength
30 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
MIRTAZAPINE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui314111

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
71335-0964-1Mirtazapine30 in 1 BOTTLETABLET, FILM COATED3011
71335-0964-2Mirtazapine56 in 1 BOTTLETABLET, FILM COATED5611
71335-0964-3Mirtazapine15 in 1 BOTTLETABLET, FILM COATED1511
71335-0964-4Mirtazapine90 in 1 BOTTLETABLET, FILM COATED9011
71335-0964-5Mirtazapine60 in 1 BOTTLETABLET, FILM COATED6011
71335-0964-6Mirtazapine28 in 1 BOTTLETABLET, FILM COATED2811
71335-0964-7Mirtazapine45 in 1 BOTTLETABLET, FILM COATED4511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0964-1EA - Each71335-09642c3afedb-87e5-4b74-92cd-61bc3f945d2112019-11-12
71335-0964-4EA - Each71335-0964318d7545-f8fd-4842-92c8-c3549a8deaf612025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0964MIRTAZAPINE TABLET, FILM COATED [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 7 package rows20240410_1fb26f9b-b075-471d-8cc3-fa39246ec2e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314111mirtazapine 30 MG Oral TabletPSN1fb26f9b-b075-471d-8cc3-fa39246ec2e411
314111mirtazapine 30 MG Oral TabletSCD1fb26f9b-b075-471d-8cc3-fa39246ec2e411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0964-17133509640130 TABLET, FILM COATED in 1 BOTTLE (71335-0964-1) 2018-10-080000-00-00NoNoCurrent
71335-0964-27133509640256 TABLET, FILM COATED in 1 BOTTLE (71335-0964-2) 2024-04-090000-00-00NoNoCurrent
71335-0964-37133509640315 TABLET, FILM COATED in 1 BOTTLE (71335-0964-3) 2020-08-100000-00-00NoNoCurrent
71335-0964-47133509640490 TABLET, FILM COATED in 1 BOTTLE (71335-0964-4) 2019-08-080000-00-00NoNoCurrent
71335-0964-57133509640560 TABLET, FILM COATED in 1 BOTTLE (71335-0964-5) 2024-04-090000-00-00NoNoCurrent
71335-0964-67133509640628 TABLET, FILM COATED in 1 BOTTLE (71335-0964-6) 2024-04-090000-00-00NoNoCurrent
71335-0964-77133509640745 TABLET, FILM COATED in 1 BOTTLE (71335-0964-7) 2024-04-09NoNoCurrent