0143-9393 : Remifentanil Hydrochloride 5 mg/5ml Intravenous Injection, Powder, Lyophilized, for Solution


NDC0143-9393
Labeler: Hikma Pharmaceuticals USA Inc.
Product Type: Human Prescription Drug
Drug Name:  Remifentanil Hydrochloride
Dosage Form: Intravenous Injection, Powder, Lyophilized, for Solution
Application #: ANDA210594
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:

  • 0143-9393-10: 10 VIAL IN 1 CARTON (0143‑9393‑10) > 10 ML IN 1 VIAL (0143‑9393‑01)

Active Ingredients:

  • Remifentanil Hydrochloride

Dosage Strength:

  • 5 mg/5mL

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 0143-9391 Remifentanil Hydrochloride 1 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Hikma Pharmaceuticals USA Inc.
  • 0143-9392 Remifentanil Hydrochloride 2 mg/2ml Intravenous Injection, Powder, Lyophilized, for Solution by Hikma Pharmaceuticals USA Inc.
  • 63323-723 Remifentanil Hydrochloride 1 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Fresenius Kabi USA, LLC
  • 63323-724 Remifentanil Hydrochloride 1 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Fresenius Kabi USA, LLC
  • 63323-725 Remifentanil Hydrochloride 1 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Fresenius Kabi USA, LLC
  • 68475-505 Remifentanil Hydrochloride 1 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Navinta LLC
  • 68475-506 Remifentanil Hydrochloride 2 mg/2ml Intravenous Injection, Powder, Lyophilized, for Solution by Navinta LLC
  • 68475-507 Remifentanil Hydrochloride 5 mg/5ml Intravenous Injection, Powder, Lyophilized, for Solution by Navinta LLC

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