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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

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