Selegiline Hydrochloride
Selegiline Hydrochloride Tablets USP 5 mg
2aa9f8ee-6a86-6cf1-bec7-6a1ffa5e1ae2
HUMAN PRESCRIPTION DRUG LABEL
Sep 22, 2025
Apotex Corp.
DUNS: 845263701
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
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL-5 mg BOTTLE LABEL
Representative sample of labeling (seeHOW SUPPLIED section for completed listing):
APOTEX CORP. NDC 60505-3438-3
SELEGILINE HYDROCHLORIDE TABLETS USP
5 mg
Rx Only
60 Tablets
DESCRIPTION SECTION
DESCRIPTION
Selegiline hydrochloride is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl.
The chemical name is: (R)-(-)-N,2-dimethyl-N-2-propynylphenethylamine hydrochloride. It is a white to near white crystalline powder, freely soluble in water, chloroform, and methanol, and has a molecular weight of 223.75. The molecular formula is C13H17•HCl. The structural formula is as follows:
Each tablet, for oral administration, contains 5 mg selegiline hydrochloride. Inactive ingredients are citric acid, anhydrous lactose, magnesium stearate, and microcrystalline cellulose.
HOW SUPPLIED SECTION
HOW SUPPLIED
Selegiline Hydrochloride Tablets USP 5 mg are available for oral
administration as white or slightly mottled, round, unscored tablets imprinted
with 
on
one side and “3438” on the other side. They are supplied as bottles of 60 (NDC
60505-3438-3) and bottles of 500 (NDC 60505-3438-8).
Storage
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in a tight, light-resistant container [see USP] with a child- resistant closure as required.
APOTEX INC.
SELEGILINE HYDROCHLORIDE TABLETS USP
5 mg
Manufactured by: Manufactured for:
Apotex Inc. Apotex Corp.
Toronto, Ontario Weston, Florida
Canada M9L 1T9 33326
Revised: June 2009
Rev. 1