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
a62a9946-755f-47d0-afe6-edc8f7d641fe
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2022
Manufacturers
FDA
Alvogen, Inc.
DUNS: 008057330
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 Code47781-683
Application NumberANDA201970
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rasagiline
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2019
FDA Product Classification
INGREDIENTS (6)
Rasagiline MesylateActive
Quantity: 0.5 mg in 1 1
Code: LH8C2JI290
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
Rasagiline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47781-690
Application NumberANDA201970
Product Classification
M
Marketing Category
C73584
G
Generic Name
Rasagiline
Product Specifications
Route of AdministrationORAL
Effective DateMarch 27, 2019
FDA Product Classification
INGREDIENTS (6)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Rasagiline MesylateActive
Quantity: 1 mg in 1 1
Code: LH8C2JI290
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT