71288-505 : Dexmedetomidine 100 ug/ml Intravenous Injection, Solution


NDC: 71288-505
Labeler: Meitheal Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name:  Dexmedetomidine
Dosage Form: Intravenous Injection, Solution
Application #: ANDA204843
Rev. Date: 


NDC Package Codes:

  • 71288-505-03: 25 VIAL, SINGLE‑DOSE IN 1 CARTON (71288‑505‑03) > 2 ML IN 1 VIAL, SINGLE‑DOSE (71288‑505‑02)

Active Ingredients:

  • Dexmedetomidine Hydrochloride

Dosage Strength:

  • 100 ug/mL

Pharmaceutical Classes:

  • Adrenergic alpha2-Agonists [MoA]
  • Central alpha-2 Adrenergic Agonist [EPC]
  • General Anesthesia [PE]

Related Products:

Based on records with the same trade name.
  • 17478-055 Dexmedetomidine 100 ug/ml Intravenous Injection, Solution, Concentrate by Akorn, Inc.
  • 66794-230 Dexmedetomidine 200 ug/2ml Intravenous Injection, Solution by Piramal Critical Care Inc
  • 66794-233 Dexmedetomidine 200 ug/2ml Intravenous Injection, Solution by Piramal Critical Care Inc
  • 66794-238 Dexmedetomidine 100 ug/ml Intravenous Injection, Solution by Piramal Critical Care Inc
  • 68083-527 Dexmedetomidine 100 ug/ml Intravenous Injection, Solution by Gland Pharma Limited
  • 71872-7150 Dexmedetomidine 100 ug/ml Intravenous Injection, Solution, Concentrate by Medical Purchasing Solutions, LLC.
  • 71872-7323 Dexmedetomidine 200 ug/2ml Intravenous Injection, Solution by Medical Purchasing Solutions, LLC
  • 83634-600 Dexmedetomidine 100 ug/ml Intravenous Injection, Solution, Concentrate by Avenacy 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.