Rasagiline

Product NDC
47781-683
11-digit product format
477810683
Labeler code
47781
Product ID
47781-683_9726c72c-4d6a-6707-a9bf-e3716476f816
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rasagiline
Dosage form
TABLET
Route
ORAL
Labeler
Alvogen, Inc.
Application
ANDA201970
Marketing category
ANDA
Marketing start
2019-03-01
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
47781-683-30Rasagiline30 in 1 BOTTLE, PLASTICTABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-683-30EA - Each47781-6830c585f52-aa39-4ee0-ae46-fa791b58fdf512019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-683RASAGILINE TABLET [ALVOGEN, INC.]6Current NDC, Legacy NDC, 1 package rows20241012_a62a9946-755f-47d0-afe6-edc8f7d641fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636664rasagiline 0.5 MG Oral TabletPSNa62a9946-755f-47d0-afe6-edc8f7d641fe7
608328rasagiline 1 MG Oral TabletPSNa62a9946-755f-47d0-afe6-edc8f7d641fe7
636664rasagiline 0.5 MG Oral TabletSCDa62a9946-755f-47d0-afe6-edc8f7d641fe7
608328rasagiline 1 MG Oral TabletSCDa62a9946-755f-47d0-afe6-edc8f7d641fe7
636664rasagiline (as rasagiline mesylate) 0.5 MG Oral TabletSYa62a9946-755f-47d0-afe6-edc8f7d641fe7
608328rasagiline (as rasagiline mesylate) 1 MG Oral TabletSYa62a9946-755f-47d0-afe6-edc8f7d641fe7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-683-304778106833030 TABLET in 1 BOTTLE, PLASTIC (47781-683-30) 30 tablet2019-03-010000-00-00NoNoCurrent