RASAGILINE

Product NDC
13668-446
11-digit product format
136680446
Labeler code
13668
Product ID
13668-446_fa1b2a7e-f459-4432-97f2-23d2c07c2dac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
RASAGILINE
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA210150
Marketing category
ANDA
Marketing start
2025-11-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
RASAGILINE
Listing expiration
2027-12-31

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-446-05RASAGILINE500 in 1 CONTAINERTABLET5006
13668-446-30RASAGILINE30 in 1 CONTAINERTABLET306
13668-446-90RASAGILINE90 in 1 CONTAINERTABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-446-30EA - Each13668-446d192e824-83a5-44f1-84b7-9862db9af55512026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636664rasagiline 0.5 MG Oral TabletPSN2c5e3cde-1158-4b5a-9a2b-ea6c987a65e46
608328rasagiline 1 MG Oral TabletPSN2c5e3cde-1158-4b5a-9a2b-ea6c987a65e46
636664rasagiline 0.5 MG Oral TabletSCD2c5e3cde-1158-4b5a-9a2b-ea6c987a65e46
608328rasagiline 1 MG Oral TabletSCD2c5e3cde-1158-4b5a-9a2b-ea6c987a65e46
636664rasagiline (as rasagiline mesylate) 0.5 MG Oral TabletSY2c5e3cde-1158-4b5a-9a2b-ea6c987a65e46
608328rasagiline (as rasagiline mesylate) 1 MG Oral TabletSY2c5e3cde-1158-4b5a-9a2b-ea6c987a65e46

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13668-446-0513668044605500 TABLET in 1 CONTAINER (13668-446-05) 500 tablet2025-11-15NoNoHistorical
13668-446-301366804463030 TABLET in 1 CONTAINER (13668-446-30) 30 tablet2025-11-15NoNoHistorical
13668-446-901366804469090 TABLET in 1 CONTAINER (13668-446-90) 90 tablet2025-11-15NoNoHistorical