Rasagiline
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for .Rasagiline Tablets for Oral UseInitial U.S. Approval:
Approved
Approval ID
e802c83c-e581-4a11-b83d-1df47120078d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2020
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rasagiline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-3061
Application NumberNDA021641
Product Classification
M
Marketing Category
C73605
G
Generic Name
Rasagiline
Product Specifications
Route of AdministrationORAL
Effective DateAugust 24, 2023
FDA Product Classification
INGREDIENTS (6)
RASAGILINE MESYLATEActive
Quantity: 1 mg in 1 1
Code: LH8C2JI290
Classification: ACTIM
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Rasagiline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0093-3060
Application NumberNDA021641
Product Classification
M
Marketing Category
C73605
G
Generic Name
Rasagiline
Product Specifications
Route of AdministrationORAL
Effective DateAugust 24, 2023
FDA Product Classification
INGREDIENTS (6)
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
RASAGILINE MESYLATEActive
Quantity: 0.5 mg in 1 1
Code: LH8C2JI290
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT