OLINVYK Solution for injection Ref.[10350] Active ingredients:

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

The active ingredient in OLINVYK is oliceridine, an opioid agonist. Oliceridine fumarate is a white to lightly-colored solid that is sparingly soluble in water. The chemical name for oliceridine fumarate is [(3-methoxythiophen-2-yl)methyl]({2-[(9R)9(pyridin-2-yl)-6-oxaspiro[4.5]decan-9-yl]ethyl})amine fumarate, and the molecular formula is C22H30N2O2SยทC4H4O4. The theoretical average molecular mass is 502.62 (fumarate salt) and 386.55 (free base).

The structural formula of oliceridine fumarate is:

OLINVYK (oliceridine) injection is a clear, colorless, sterile, preservative-free solution, pH 6.4 to 7.4, in a glass vial for intravenous use.

Each milliliter of the solution contains 1.0 mg of oliceridine free base (1.3 mg of oliceridine fumarate salt), as well as L-histidine and mannitol, in water for injection.

Dosage Forms and Strengths

Injection: clear, colorless, sterile, preservative-free solution for intravenous use supplied as follows:

  • 1 mg/mL, equivalent to 1.3 mg/mL oliceridine fumarate salt, in single-dose, 2 mL, clear glass vials with gray plastic flip-off caps
  • 2 mg/2 mL (1 mg/mL), equivalent to 2.6 mg/2 mL (1.3 mg/mL) oliceridine fumarate salt, in single-dose, 2 mL, clear glass vials with orange plastic flip-off caps
  • 30 mg/30 mL (1 mg/mL), equivalent to 39 mg/30 mL (1.3 mg/mL) oliceridine fumarate salt, in single-patient-use, 30 mL, clear glass vials with purple plastic flip-off caps. For PCA Use Only.
How Supplied

OLINVYK (oliceridine) injection is a clear, colorless, preservative free solution for intravenous use supplied as follows:

NDC# 71308-011-10: 1 mg/mL, sterile solution in single-dose, 2 mL clear glass vials with gray stoppers topped with overseals with gray plastic flip-off caps (carton of 10 vials)

NDC# 71308-021-10: 2 mg/2 mL (1 mg/mL), sterile solution in single-dose, 2 mL clear glass vials with gray stoppers topped with overseals with orange plastic flip-off caps (carton of 10 vials)

NDC# 71308-301-10: 30 mg/30 mL (1 mg/mL), sterile solution in single-patient-use, 30 mL clear glass vials with gray stoppers topped with overseals with purple plastic flip-off caps (carton of 10 vials). For PCA Use Only.

Drugs

Drug Countries
OLINVYK United States

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