52584-589 : Midazolam 5 mg/ml Intramuscular; Intravenous Injection, Solution


NDC: 52584-589
Labeler: General Injectables & Vaccines, Inc.
Product Type: Human Prescription Drug
Drug Name:  Midazolam
Dosage Form: Intramuscular; Intravenous Injection, Solution
Application #: ANDA090850
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:

  • 52584-589-22: 1 VIAL, MULTI‑DOSE IN 1 BAG (52584‑589‑22) > 10 ML IN 1 VIAL, MULTI‑DOSE

Active Ingredients:

  • Midazolam Hydrochloride

Dosage Strength:

  • 5 mg/mL

Pharmaceutical Classes:

  • Benzodiazepine [EPC]
  • Benzodiazepines [CS]

Related Products:

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  • 0641-6059 Midazolam 1 mg/ml Intramuscular; Intravenous Injection by West-ward Pharmaceutical Corp.
  • 0641-6060 Midazolam 5 mg/ml Intramuscular; Intravenous Injection by West-ward Pharmaceutical Corp.
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