Selegiline Hydrochloride
Selegiline Hydrochloride Tablets, USP 5 mg
Approved
Approval ID
c81e983b-455d-2e65-e053-2a95a90a3123
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 11, 2023
Manufacturers
FDA
i3 Pharmaceuticals, LLC
DUNS: 080127275
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 Code72319-006
Application NumberANDA074672
Product Classification
M
Marketing Category
C73584
G
Generic Name
Selegiline Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2021
FDA Product Classification
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
MICROCRYSTALLINE CELLULOSE 101Inactive
Code: 7T9FYH5QMK
Classification: IACT
SELEGILINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 6W731X367Q
Classification: ACTIB