FDA.reportPublic FDA data

Rasagiline

Product NDC
83085-008
11-digit product format
830850008
Labeler code
83085
Product ID
83085-008_9ce75c86-75fb-4e5d-a5a6-25696c5593f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rasagiline mesylate
Dosage form
TABLET
Route
ORAL
Labeler
SKG Pharma Inc.
Application
ANDA218163
Marketing category
ANDA
Marketing start
2025-04-04
Substance
RASAGILINE MESYLATE
Active strength
1 mg/1
Pharmacologic classes
Monoamine Oxidase Inhibitor [EPC], Monoamine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rasagiline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RASAGILINE MESYLATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLH8C2JI290
Rxcui608328, 636664

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e9145103-bd6e-1983-a11c-ef9ba78a1125Product name920250303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83085-008-10Rasagiline1000 in 1 BOTTLETABLET10003
83085-008-30Rasagiline30 in 1 BOTTLETABLET303
83085-008-50Rasagiline500 in 1 BOTTLETABLET5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83085-008RASAGILINE (RASAGILINE MESYLATE) TABLET [SKG PHARMA INC.]3Current NDC, 3 package rows20250406_5c234b28-29e7-4149-9505-e2818a692bca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636664rasagiline 0.5 MG Oral TabletPSN5c234b28-29e7-4149-9505-e2818a692bca3
608328rasagiline 1 MG Oral TabletPSN5c234b28-29e7-4149-9505-e2818a692bca3
636664rasagiline 0.5 MG Oral TabletSCD5c234b28-29e7-4149-9505-e2818a692bca3
608328rasagiline 1 MG Oral TabletSCD5c234b28-29e7-4149-9505-e2818a692bca3
636664rasagiline (as rasagiline mesylate) 0.5 MG Oral TabletSY5c234b28-29e7-4149-9505-e2818a692bca3
608328rasagiline (as rasagiline mesylate) 1 MG Oral TabletSY5c234b28-29e7-4149-9505-e2818a692bca3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83085-008-10830850008101000 TABLET in 1 BOTTLE (83085-008-10) 1000 tablet2025-04-04NoNoCurrent
83085-008-308308500083030 TABLET in 1 BOTTLE (83085-008-30) 30 tablet2025-04-04NoNoCurrent
83085-008-5083085000850500 TABLET in 1 BOTTLE (83085-008-50) 500 tablet2025-04-04NoNoCurrent