ZELAPAR
These highlights do not include all the information needed to use ZELAPAR safely and effectively. See full prescribing information for ZELAPAR.ZELAPAR (selegiline hydrochloride) orally disintegrating tabletsInitial U.S. Approval: 2006
Approved
Approval ID
380d7717-2a79-42f3-a712-efe5e7696ba0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 1, 2021
Manufacturers
FDA
Bausch Health US, LLC
DUNS: 831922468
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SELEGILINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0187-0453
Application NumberNDA021479
Product Classification
M
Marketing Category
C73594
G
Generic Name
SELEGILINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJune 1, 2021
FDA Product Classification
INGREDIENTS (7)
SELEGILINE HYDROCHLORIDEActive
Quantity: 1.25 mg in 1 1
Code: 6W731X367Q
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ASPARTAMEInactive
Code: Z0H242BBR1
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT