Rasagiline
These highlights do not include all the information needed to use RASAGILINE TABLETS safely and effectively. See full prescribing information for RASAGILINE TABLETS. RASAGILINE tablets for oral use Initial U.S. Approval: 2006
Approved
Approval ID
8bf8e76c-27cb-42a4-aa9c-bdade68c463b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
NorthStar RxLLC
DUNS: 830546433
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 Code16714-770
Application NumberANDA201889
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rasagiline
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2020
FDA Product Classification
INGREDIENTS (7)
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
RASAGILINE MESYLATEActive
Quantity: 0.5 mg in 1 1
Code: LH8C2JI290
Classification: ACTIM
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 Code16714-771
Application NumberANDA201889
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rasagiline
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 15, 2020
FDA Product Classification
INGREDIENTS (7)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
RASAGILINE MESYLATEActive
Quantity: 1 mg in 1 1
Code: LH8C2JI290
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT