Rasagiline
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for .Rasagiline Tablets for Oral UseInitial U.S. Approval:
e802c83c-e581-4a11-b83d-1df47120078d
HUMAN PRESCRIPTION DRUG LABEL
Jun 30, 2020
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Rasagiline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Rasagiline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (6)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package/Label Display Panel
NDC 0093-3061-56
Rasagiline
Tablets
1 mg
Rx only
30 Tablets
teva
DESCRIPTION SECTION
11 DESCRIPTION
Rasagiline tablets contain rasagiline (as the mesylate), a propargylamine- based drug indicated for the treatment of idiopathic Parkinson’s disease. Rasagiline mesylate is designated chemically as: 1H-Inden-1-amine, 2, 3-dihydro-N-2-propynyl-, (1R)-, methanesulfonate. The empirical formula of rasagiline mesylate is C12H13N•CH4SO3 and its molecular weight is 267.34.
Its structural formula is:
Rasagiline mesylate is a white to off-white powder, freely soluble in water or ethanol and sparingly soluble in isopropanol. Each rasagiline tablet for oral administration contains 0.5 mg or 1 mg of rasagiline (equivalent to 0.78 mg or 1.56 mg of rasagiline mesylate).
Each rasagiline tablet also contains the following inactive ingredients: mannitol, starch, pregelatinized starch, colloidal silicon dioxide, stearic acid, and talc.