12496-0757 : Buprenex .3 mg/ml Intramuscular; Intravenous Injection, Solution


NDC12496-0757
Labeler: Reckitt Benckiser Pharmaceuticals Inc
Product Type: Human Prescription Drug
Drug Name:  Buprenex
Dosage Form: Intramuscular; Intravenous Injection, Solution
Application #: NDA018401
Rev. Date: 
CSA Schedule: CIII (US) [1]


[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 12496-0757-1: 5 AMPULE IN 1 CARTON (12496‑0757‑1) > 1 ML IN 1 AMPULE
  • 12496-0757-5: 5 AMPULE IN 1 CARTON (12496‑0757‑5) > 1 ML IN 1 AMPULE (12496‑0757‑1)

Active Ingredients:

  • Buprenorphine Hydrochloride

Dosage Strength:

  • .3 mg/mL

Pharmaceutical Classes:

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

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