Selegiline Hydrochloride
Selegiline Hydrochloride Capsules, USP Rx only
Approved
Approval ID
e42d99b0-c62e-49d4-b792-1301bb539b92
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 1, 2021
Manufacturers
FDA
Novitium Pharma LLC
DUNS: 080301870
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 Code70954-504
Application NumberANDA075352
Product Classification
M
Marketing Category
C73584
G
Generic Name
Selegiline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 13, 2021
FDA Product Classification
INGREDIENTS (15)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SELEGILINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 6W731X367Q
Classification: ACTIB
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: MB5IUD6JUA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT