Source: FDA, National Drug Code (US) Revision Year: 2018
Phentolamine mesylate is phenol,3-[[(4,5-dihydro-1H-imidazol-2-yl)methyl](4-methyl-phenyl)amino]-,methanesulfonate (salt), a non-specific alpha adrenergic blocker.
Phentolamine mesylate USP is a white to off-white, odorless crystalline powder with a molecular weight of 377.46. It is sparingly soluble in water, soluble in alcohol, and slightly soluble in chloroform. The empirical formulation is C17H19N3O•CH4O3S, and the chemical structure is:
OraVerse (phentolamine mesylate) Injection is a clear, colorless, sterile, non pyrogenic, isotonic, preservative free solution. Each 1.7 mL cartridge contains 0.4 mg phentolamine mesylate, D-mannitol, edetate disodium, and sodium acetate. Either acetic acid or sodium hydroxide is used as necessary to adjust the pH.
| Dosage Forms and Strengths |
|---|
|
0.4 mg/1.7 mL solution per cartridge. |
| How Supplied |
|---|
|
OraVerse (phentolamine mesylate) Injection 0.4 mg/1.7 mL is supplied in a dental cartridge, in cartons of 10 and 50 cartridges. Each cartridge is individually packaged in a separate compartment of a 10 cartridge blister pack. NDC 0362-0101-50 Manufactured by Novocol Pharmaceutical of Canada, Inc., Cambridge, Ontario, Canada for Septodont, Inc, Louisville, CO 80027 |
| Drug | Countries | |
|---|---|---|
| ORAVERSE | Canada, France, United States |
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