0378-9639 : Butorphanol Tartrate 10 mg/ml Nasal Spray


NDC0378-9639
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Butorphanol Tartrate
Dosage Form: Nasal Spray
Application #: ANDA075759
Rev. Date: 
CSA Schedule: CIV (US) [1]


[1] Schedule IV Controlled Substance: Low potential for abuse relative to substances in Schedule III. Examples include Alprazolam (Xanax), Diazepam (Valium), Carisoprodol (Soma), Clonazepam (Klonopin), Lorazepam (Ativan), Clorazepate (Tranxene), Midazolam (Versed), Temazepam (Restoril), and Triazolam (Halcion).. More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

  • 0378-9639-43: 2.5 ML IN 1 VIAL, MULTI‑DOSE (0378‑9639‑43)

Active Ingredients:

  • Butorphanol Tartrate

Dosage Strength:

  • 10 mg/mL

Pharmaceutical Classes:

  • Competitive Opioid Antagonists [MoA]
  • Opioid Agonist/Antagonist [EPC]
  • Partial Opioid Agonists [MoA]

Related Products:

Based on records with the same trade name.
  • 0054-3090 Butorphanol Tartrate 10 mg/ml Nasal Spray, Metered by Roxane Laboratories, Inc
  • 0143-9864 Butorphanol Tartrate 1 mg/ml Intramuscular; Intravenous Injection, Solution by West-ward Pharmaceutical Corp
  • 0143-9867 Butorphanol Tartrate 2 mg/ml Intramuscular; Intravenous Injection, Solution by West-ward Pharmaceutical Corp
  • 0409-1623 Butorphanol Tartrate 1 mg/ml Intramuscular; Intravenous Injection, Solution by Hospira, Inc.
  • 0409-1626 Butorphanol Tartrate 2 mg/ml Intramuscular; Intravenous Injection, Solution by Hospira, Inc.
  • 52584-626 Butorphanol Tartrate 2 mg/ml Intramuscular; Intravenous Injection, Solution by General Injectables & Vaccines, Inc
  • 54569-5988 Butorphanol Tartrate 10 mg/ml Nasal Spray, Metered by A-s Medication Solutions LLC
  • 55154-0366 Butorphanol Tartrate 2 mg/ml Intramuscular; Intravenous Injection by Cardinal Health
  • 55154-0367 Butorphanol Tartrate 1 mg/ml Intramuscular; Intravenous Injection by Cardinal Health
  • 60505-0813 Butorphanol Tartrate 10 mg/ml Nasal Solution by Apotex Corp.
  • 72162-2099 Butorphanol Tartrate 10 mg/ml Nasal Spray by Bryant Ranch Prepack

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.