Mirtazapine

Product NDC
63739-099
11-digit product format
637390099
Labeler code
63739
Product ID
63739-099_2bb25f3c-7005-6710-e063-6294a90a022c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mirtazapine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA077666
Marketing category
ANDA
Marketing start
2007-08-22
Marketing end
2027-03-31
Substance
MIRTAZAPINE
Active strength
30 mg/1
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mirtazapine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRTAZAPINE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiA051Q2099Q
Rxcui311725, 314111

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63739-099-10Mirtazapine10 in 1 BLISTER PACKTABLET, FILM COATED1011
63739-099-10Mirtazapine10 in 1 BOXTABLET, FILM COATED1011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-099-10EA - Each63739-099464d6ecb-9986-4554-b324-536a110a639212020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-099MIRTAZAPINE TABLET, FILM COATED [MCKESSON CORPORATION DBA SKY PACKAGING]11Current NDC, Legacy NDC, 2 package rows20250116_40c95daa-bbd5-48d9-97e4-c87f2c1f0fa5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311725mirtazapine 15 MG Oral TabletPSN40c95daa-bbd5-48d9-97e4-c87f2c1f0fa511
314111mirtazapine 30 MG Oral TabletPSN40c95daa-bbd5-48d9-97e4-c87f2c1f0fa511
311725mirtazapine 15 MG Oral TabletSCD40c95daa-bbd5-48d9-97e4-c87f2c1f0fa511
314111mirtazapine 30 MG Oral TabletSCD40c95daa-bbd5-48d9-97e4-c87f2c1f0fa511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-099-106373900991010 BLISTER PACK in 1 BOX (63739-099-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2019-11-152027-03-31NoNoCurrent