Rasagiline
Rasagiline Tablets Rx only These highlights do not include all the information needed to use rasagiline safely and effectively. See full prescribing information for rasagiline. Initial U.S. Approval: 2006
Approved
Approval ID
c2c8a281-065a-faf5-e053-2995a90aa13f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2023
Manufacturers
FDA
AvKARE
DUNS: 796560394
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 Code42291-779
Application NumberNDA021641
Product Classification
M
Marketing Category
C73605
G
Generic Name
Rasagiline
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (6)
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 MESYLATEActive
Quantity: 0.5 mg in 1 1
Code: LH8C2JI290
Classification: ACTIM
Rasagiline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42291-780
Application NumberNDA021641
Product Classification
M
Marketing Category
C73605
G
Generic Name
Rasagiline
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2023
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
RASAGILINE MESYLATEActive
Quantity: 1 mg in 1 1
Code: LH8C2JI290
Classification: ACTIM