71053-595 : N/A 10 mg/.7ml Intramuscular Injection, Solution


NDC71053-595
Labeler: Rafa Laboratories, Ltd.
Product Type: Human Prescription Drug
Drug Name:  N/A
Dosage Form: Intramuscular Injection, Solution
Application #: NDA216359
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:

  • 71053-595-01: 480 CARTON IN 1 BOX (71053‑595‑01) > 40 SYRINGE IN 1 CARTON > .7 ML IN 1 SYRINGE

Active Ingredients:

  • Midazolam

Dosage Strength:

  • 10 mg/.7mL

Pharmaceutical Classes:

  • Benzodiazepine [EPC]
  • Benzodiazepines [CS]

Related Products:

Based on records with the same trade name.
  • 71053-590 N/A .5 mg/.7ml Intramuscular Injection by Rafa Laboratories, Ltd.
  • 71053-591 N/A 1 mg/.7ml Intramuscular Injection by Rafa Laboratories, Ltd.
  • 71053-592 N/A 2 mg/.7ml Intramuscular Injection by Rafa Laboratories, Ltd.
  • 0054-9628 N/A .5 g/ml Oral Solution by Hikma Pharmaceuticals USA Inc.
  • 0517-0920 N/A 6 mg/ml Intravenous Injection by American Regent, Inc.
  • 43386-405 N/A 500 mg Oral Tablet by Lupin Pharmaceuticals, Inc.

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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.