Mirtazapine

Product NDC
71335-0441
11-digit product format
713350441
Labeler code
71335
Product ID
71335-0441_ecc9d098-2d04-4636-a062-ee78eb087819
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076541
Marketing category
ANDA
Marketing start
2004-04-22
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
71335-0441-1Mirtazapine30 in 1 BOTTLETABLET30101
71335-0441-2Mirtazapine56 in 1 BOTTLETABLET56101
71335-0441-3Mirtazapine15 in 1 BOTTLETABLET15101
71335-0441-4Mirtazapine90 in 1 BOTTLETABLET90101
71335-0441-5Mirtazapine60 in 1 BOTTLETABLET60101
71335-0441-6Mirtazapine28 in 1 BOTTLETABLET28101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0441-4EA - Each71335-044110b1a35c-1e4a-4e7b-9bef-914f40eac7fe12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0441MIRTAZAPINE TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 6 package rows20231026_577c3ceb-316b-4c93-9b0c-0a4b1b4773e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314111mirtazapine 30 MG Oral TabletPSN577c3ceb-316b-4c93-9b0c-0a4b1b4773e9101
314111mirtazapine 30 MG Oral TabletSCD577c3ceb-316b-4c93-9b0c-0a4b1b4773e9101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0441-17133504410130 TABLET in 1 BOTTLE (71335-0441-1) 30 tablet2022-02-090000-00-00NoNoCurrent
71335-0441-27133504410256 TABLET in 1 BOTTLE (71335-0441-2) 56 tablet2022-02-090000-00-00NoNoCurrent
71335-0441-37133504410315 TABLET in 1 BOTTLE (71335-0441-3) 15 tablet2022-02-090000-00-00NoNoCurrent
71335-0441-47133504410490 TABLET in 1 BOTTLE (71335-0441-4) 90 tablet2022-02-090000-00-00NoNoCurrent
71335-0441-57133504410560 TABLET in 1 BOTTLE (71335-0441-5) 60 tablet2022-02-090000-00-00NoNoCurrent
71335-0441-67133504410628 TABLET in 1 BOTTLE (71335-0441-6) 28 tablet2022-02-090000-00-00NoNoCurrent