Rasagiline

Product NDC
64980-711
11-digit product format
649800711
Labeler code
64980
Product ID
64980-711_27e4574d-642e-4443-bd54-50b4244d52c8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rasagiline mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA218163
Marketing category
ANDA
Marketing start
2025-07-21
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
64980-711-30Rasagiline30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-711-30EA - Each64980-711725ed59a-362a-4b43-9312-ab14b9e0173a12025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636664rasagiline 0.5 MG Oral TabletPSN7d9eac3f-7441-45cf-a603-ea18c116e2c01
608328rasagiline 1 MG Oral TabletPSN7d9eac3f-7441-45cf-a603-ea18c116e2c01
636664rasagiline 0.5 MG Oral TabletSCD7d9eac3f-7441-45cf-a603-ea18c116e2c01
608328rasagiline 1 MG Oral TabletSCD7d9eac3f-7441-45cf-a603-ea18c116e2c01
636664rasagiline (as rasagiline mesylate) 0.5 MG Oral TabletSY7d9eac3f-7441-45cf-a603-ea18c116e2c01
608328rasagiline (as rasagiline mesylate) 1 MG Oral TabletSY7d9eac3f-7441-45cf-a603-ea18c116e2c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-711-306498007113030 TABLET in 1 BOTTLE (64980-711-30) 30 tablet2025-07-21NoNoHistorical