67457-198 : Ultiva 1 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution


NDC67457-198
Labeler: Mylan Institutional LLC
Product Type: Human Prescription Drug
Drug Name:  Ultiva
Dosage Form: Intravenous Injection, Powder, Lyophilized, for Solution
Application #: NDA020630
Rev. Date: 
CSA Schedule: CII (US) [1]


[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 67457-198-03: 10 VIAL, GLASS IN 1 CARTON (67457‑198‑03) > 3 ML IN 1 VIAL, GLASS (67457‑198‑00)
  • 67457-198-05: 10 VIAL, GLASS IN 1 CARTON (67457‑198‑05) > 5 ML IN 1 VIAL, GLASS (67457‑198‑99)
  • 67457-198-10: 10 VIAL, GLASS IN 1 CARTON (67457‑198‑10) > 10 ML IN 1 VIAL, GLASS (67457‑198‑98)

Active Ingredients:

  • Remifentanil Hydrochloride

Dosage Strength:

  • 1 mg/mL

Pharmaceutical Classes:

  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 67457-912 Ultiva 1 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Mylan Institutional LLC
  • 67457-913 Ultiva 1 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Mylan Institutional LLC
  • 67457-914 Ultiva 1 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Mylan Institutional LLC
  • 72078-034 Ultiva 1 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Mylan Institutional LLC
  • 72078-035 Ultiva 1 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Mylan Institutional LLC
  • 72078-036 Ultiva 1 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Mylan Institutional LLC

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