Rasagiline

Product NDC
62135-676
11-digit product format
621350676
Labeler code
62135
Product ID
62135-676_17dd92b2-969b-16f1-e063-6394a90aee89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rasagiline
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA201892
Marketing category
ANDA
Marketing start
2018-07-27
Substance
RASAGILINE MESYLATE
Active strength
.5 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 MESYLATE.5 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
62135-676-30Rasagiline30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-676-30EA - Each62135-676eb05db0b-8b07-4f5e-b65f-41f06bc731f112024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-676RASAGILINE TABLET [CHARTWELL RX, LLC]1Current NDC, 1 package rows20240508_d9168d62-814a-444f-9d70-11674def339d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636664rasagiline 0.5 MG Oral TabletPSNd9168d62-814a-444f-9d70-11674def339d1
608328rasagiline 1 MG Oral TabletPSNd9168d62-814a-444f-9d70-11674def339d1
636664rasagiline 0.5 MG Oral TabletSCDd9168d62-814a-444f-9d70-11674def339d1
608328rasagiline 1 MG Oral TabletSCDd9168d62-814a-444f-9d70-11674def339d1
636664rasagiline (as rasagiline mesylate) 0.5 MG Oral TabletSYd9168d62-814a-444f-9d70-11674def339d1
608328rasagiline (as rasagiline mesylate) 1 MG Oral TabletSYd9168d62-814a-444f-9d70-11674def339d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-676-306213506763030 TABLET in 1 BOTTLE (62135-676-30) 30 tablet2024-05-01NoNoCurrent