FDA.reportPublic FDA data

Mirtazapine

Product NDC
72162-1640
11-digit product format
721621640
Labeler code
72162
Product ID
72162-1640_ec83d85a-e001-4696-8049-cb3eaa90bed8
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
72162-1640-0Mirtazapine1000 in 1 BOTTLETABLET1000105
72162-1640-2Mirtazapine45 in 1 BOTTLETABLET45105
72162-1640-3Mirtazapine30 in 1 BOTTLETABLET30105
72162-1640-5Mirtazapine500 in 1 BOTTLETABLET500105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1640-0EA - Each72162-1640ac084a68-fb02-43ed-a8ef-8ffd19a4b9b512024-08-12
72162-1640-3EA - Each72162-16403c04b732-a107-45f5-be14-c1c8adef33e612023-10-16
72162-1640-5EA - Each72162-1640da7ec548-4210-421e-9213-4b96e226949a12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1640MIRTAZAPINE TABLET [BRYANT RANCH PREPACK]104Current NDC, 4 package rows20250519_ded5b83b-f11a-4a6a-bf77-c5fe6dc4c4f5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314111mirtazapine 30 MG Oral TabletPSNded5b83b-f11a-4a6a-bf77-c5fe6dc4c4f5105
314111mirtazapine 30 MG Oral TabletSCDded5b83b-f11a-4a6a-bf77-c5fe6dc4c4f5105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1640-0721621640001000 TABLET in 1 BOTTLE (72162-1640-0) 1000 tablet2024-07-16NoNoHistorical
72162-1640-27216216400245 TABLET in 1 BOTTLE (72162-1640-2) 45 tablet2023-08-28NoNoHistorical
72162-1640-37216216400330 TABLET in 1 BOTTLE (72162-1640-3) 30 tablet2023-08-28NoNoHistorical
72162-1640-572162164005500 TABLET in 1 BOTTLE (72162-1640-5) 500 tablet2023-08-28NoNoHistorical