FDA.reportPublic FDA data

Azilect

Product NDC
68546-142
11-digit product format
685460142
Labeler code
68546
Product ID
68546-142_e90d2f30-97b1-4c76-8038-df259889e3b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rasagiline mesylate
Dosage form
TABLET
Route
ORAL
Labeler
Teva Neuroscience, Inc.
Application
NDA021641
Marketing category
NDA
Marketing start
2006-07-10
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
Azilect
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, 637185, 637218

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
68546-142-27Azilect1 in 1 CARTONTABLET125
68546-142-27Azilect7 in 1 BLISTER PACKTABLET725
68546-142-56Azilect30 in 1 BOTTLETABLET3025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68546-142-56EA - Each68546-1425a3d7c21-9b57-47ba-9047-27cf3df1654b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
RASAGILINE MESYLATEACTIVE INGREDIENTLH8C2JI290AZILECT (RASAGILINE MESYLATE) TABLET [TEVA NEUROSCIENCE, INC.]9
RASAGILINEACTIVE MOIETY003N66TS6TAZILECT (RASAGILINE MESYLATE) TABLET [TEVA NEUROSCIENCE, INC.]9
MANNITOLINACTIVE INGREDIENT3OWL53L36AAZILECT (RASAGILINE MESYLATE) TABLET [TEVA NEUROSCIENCE, INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZILECT (RASAGILINE MESYLATE) TABLET [TEVA NEUROSCIENCE, INC.]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZILECT (RASAGILINE MESYLATE) TABLET [TEVA NEUROSCIENCE, INC.]9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAZILECT (RASAGILINE MESYLATE) TABLET [TEVA NEUROSCIENCE, INC.]9
TALCINACTIVE INGREDIENT7SEV7J4R1UAZILECT (RASAGILINE MESYLATE) TABLET [TEVA NEUROSCIENCE, INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68546-142AZILECT (RASAGILINE MESYLATE) TABLET [TEVA NEUROSCIENCE, INC.]24Current NDC, Legacy NDC, 3 package rows20240927_a40d0e73-3f9f-4b01-979d-402c9cdaeb60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637218Azilect 0.5 MG Oral TabletPSNa40d0e73-3f9f-4b01-979d-402c9cdaeb6025
637185Azilect 1 MG Oral TabletPSNa40d0e73-3f9f-4b01-979d-402c9cdaeb6025
636664rasagiline 0.5 MG Oral TabletPSNa40d0e73-3f9f-4b01-979d-402c9cdaeb6025
608328rasagiline 1 MG Oral TabletPSNa40d0e73-3f9f-4b01-979d-402c9cdaeb6025
637218rasagiline 0.5 MG Oral Tablet [Azilect]SBDa40d0e73-3f9f-4b01-979d-402c9cdaeb6025
637185rasagiline 1 MG Oral Tablet [Azilect]SBDa40d0e73-3f9f-4b01-979d-402c9cdaeb6025
636664rasagiline 0.5 MG Oral TabletSCDa40d0e73-3f9f-4b01-979d-402c9cdaeb6025
608328rasagiline 1 MG Oral TabletSCDa40d0e73-3f9f-4b01-979d-402c9cdaeb6025
637218Azilect 0.5 MG Oral TabletSYa40d0e73-3f9f-4b01-979d-402c9cdaeb6025
637185Azilect 1 MG (as rasagiline mesylate) Oral TabletSYa40d0e73-3f9f-4b01-979d-402c9cdaeb6025
637185Azilect 1 MG Oral TabletSYa40d0e73-3f9f-4b01-979d-402c9cdaeb6025
636664rasagiline (as rasagiline mesylate) 0.5 MG Oral TabletSYa40d0e73-3f9f-4b01-979d-402c9cdaeb6025
608328rasagiline (as rasagiline mesylate) 1 MG Oral TabletSYa40d0e73-3f9f-4b01-979d-402c9cdaeb6025

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68546-142-27685460142271 in 1 CARTONHistorical
68546-142-566854601425630 TABLET in 1 BOTTLE (68546-142-56) 30 tablet2006-07-100000-00-00NoNoCurrent