Rasagiline

Product NDC
33342-309
11-digit product format
333420309
Labeler code
33342
Product ID
33342-309_1650fc1f-ed87-411c-af06-97b9ff242da7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rasagiline
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA208866
Marketing category
ANDA
Marketing start
2024-06-29
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
33342-309-07Rasagiline30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-309-07EA - Each33342-3095d667b26-3c0d-41d8-8ad0-ac81e3265dc912024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-309RASAGILINE TABLET [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 1 package rows20240719_e8771c7e-5ecf-47dc-a0fd-4d12e85631a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636664rasagiline 0.5 MG Oral TabletPSNe8771c7e-5ecf-47dc-a0fd-4d12e85631a62
608328rasagiline 1 MG Oral TabletPSNe8771c7e-5ecf-47dc-a0fd-4d12e85631a62
636664rasagiline 0.5 MG Oral TabletSCDe8771c7e-5ecf-47dc-a0fd-4d12e85631a62
608328rasagiline 1 MG Oral TabletSCDe8771c7e-5ecf-47dc-a0fd-4d12e85631a62
636664rasagiline (as rasagiline mesylate) 0.5 MG Oral TabletSYe8771c7e-5ecf-47dc-a0fd-4d12e85631a62
608328rasagiline (as rasagiline mesylate) 1 MG Oral TabletSYe8771c7e-5ecf-47dc-a0fd-4d12e85631a62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-309-073334203090730 TABLET in 1 BOTTLE (33342-309-07) 30 tablet2024-06-29NoNoHistorical