FDA.reportPublic FDA data

RASAGILINE

Product NDC
42571-221
11-digit product format
425710221
Labeler code
42571
Product ID
42571-221_362d24c1-c384-4543-e063-6294a90a6b8f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rasagiline
Dosage form
TABLET
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA207004
Marketing category
ANDA
Marketing start
2019-04-03
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
42571-221-05RASAGILINE500 in 1 BOTTLETABLET5007
42571-221-10RASAGILINE1000 in 1 BOTTLETABLET10007
42571-221-30RASAGILINE30 in 1 BOTTLETABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-221-30EA - Each42571-221752ce879-20c3-45d8-bae0-ab04daf186b612019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-221RASAGILINE (RASAGILINE) TABLET [MICRO LABS LIMITED]6Current NDC, Legacy NDC, 3 package rows20211207_42f8d62f-2c57-47bc-92e7-b28111aa8cd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
608328rasagiline 1 MG Oral TabletPSN4c4f5042-0e21-40a0-8352-bb28bb752bfa100
608328rasagiline 1 MG Oral TabletSCD4c4f5042-0e21-40a0-8352-bb28bb752bfa100
608328rasagiline (as rasagiline mesylate) 1 MG Oral TabletSY4c4f5042-0e21-40a0-8352-bb28bb752bfa100
636664rasagiline 0.5 MG Oral TabletPSN42f8d62f-2c57-47bc-92e7-b28111aa8cd17
608328rasagiline 1 MG Oral TabletPSN42f8d62f-2c57-47bc-92e7-b28111aa8cd17
636664rasagiline 0.5 MG Oral TabletSCD42f8d62f-2c57-47bc-92e7-b28111aa8cd17
608328rasagiline 1 MG Oral TabletSCD42f8d62f-2c57-47bc-92e7-b28111aa8cd17
636664rasagiline (as rasagiline mesylate) 0.5 MG Oral TabletSY42f8d62f-2c57-47bc-92e7-b28111aa8cd17
608328rasagiline (as rasagiline mesylate) 1 MG Oral TabletSY42f8d62f-2c57-47bc-92e7-b28111aa8cd17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-221-0542571022105500 TABLET in 1 BOTTLE (42571-221-05) 500 tablet2019-04-030000-00-00NoNoCurrent
42571-221-10425710221101000 TABLET in 1 BOTTLE (42571-221-10) 1000 tablet2019-04-030000-00-00NoNoCurrent
42571-221-304257102213030 TABLET in 1 BOTTLE (42571-221-30) 30 tablet2019-04-030000-00-00NoNoCurrent