83270-001 : Acetylcysteine 200 mg/ml Intravenous Injection, Solution


NDC: 83270-001
Labeler: Stelis Biopharma Limited
Product Type: Human Prescription Drug
Drug Name:  Acetylcysteine
Dosage Form: Intravenous Injection, Solution
Application #: ANDA217182
Rev. Date: 


NDC Package Codes:

  • 83270-001-04: 4 VIAL, SINGLE‑DOSE IN 1 CARTON (83270‑001‑04) / 30 ML IN 1 VIAL, SINGLE‑DOSE (83270‑001‑01)

Active Ingredients:

  • Acetylcysteine

Dosage Strength:

  • 200 mg/mL

Pharmaceutical Classes:

  • Antidote [EPC]
  • Antidote for Acetaminophen Overdose [EPC]
  • Decreased Respiratory Secretion Viscosity [PE]
  • Increased Glutathione Concentration [PE]
  • Mucolytic [EPC]
  • Reduction Activity [MoA]

Related Products:

Based on records with the same trade name.
  • 0054-3025 Acetylcysteine 100 mg/ml Oral; Respiratory (Inhalation) Solution by Roxane Laboratories, Inc.
  • 0054-3026 Acetylcysteine 200 mg/ml Oral; Respiratory (Inhalation) Solution by Roxane Laboratories, Inc.
  • 0054-3027 Acetylcysteine 100 mg/ml Oral; Respiratory (Inhalation) Solution by Roxane Laboratories, Inc.
  • 0054-3028 Acetylcysteine 200 mg/ml Oral; Respiratory (Inhalation) Solution by Roxane Laboratories, Inc.
  • 0409-3307 Acetylcysteine 100 mg/ml Endotracheal; Intragastric; Oral; Respiratory (Inhalation) Solution by Hospira, Inc.
  • 0409-3308 Acetylcysteine 200 mg/ml Endotracheal; Intragastric; Oral; Respiratory (Inhalation) Solution by Hospira, Inc.
  • 0517-7504 Acetylcysteine 100 mg/ml Respiratory (Inhalation) Inhalant by American Regent, Inc.
  • 0517-7510 Acetylcysteine 100 mg/ml Respiratory (Inhalation) Inhalant by American Regent, Inc.
  • 0517-7604 Acetylcysteine 200 mg/ml Respiratory (Inhalation) Inhalant by American Regent, Inc.
  • 0517-7610 Acetylcysteine 200 mg/ml Respiratory (Inhalation) Inhalant by American Regent, Inc.
  • 0517-7630 Acetylcysteine 200 mg/ml Respiratory (Inhalation) Inhalant by American Regent, Inc.
  • 0574-0805 Acetylcysteine 200 mg/ml Intravenous Injection by Paddock Laboratories, LLC
  • 0574-0815 Acetylcysteine 200 mg/ml Intravenous Injection by Paddock Laboratories, LLC
  • 14445-412 Acetylcysteine 200 mg/ml Intravenous Injection by Indoco Remedies Limited
  • 17478-660 Acetylcysteine 200 mg/ml Intravenous Injection by Akorn, Inc.
  • 25021-812 Acetylcysteine 200 mg/ml Intravenous Injection, Solution by Sagent Pharmaceuticals
  • 51754-0104 Acetylcysteine 200 mg/ml Intravenous Injection by Exela Pharma Sciences, LLC
  • 51754-0105 Acetylcysteine 200 mg/ml Oral; Respiratory (Inhalation) Solution by Exela Pharma Sciences, LLC
  • 54868-5670 Acetylcysteine 200 mg/ml Oral; Respiratory (Inhalation) Solution by Physicians Total Care, Inc.
  • 55150-259 Acetylcysteine 6 g/30ml Intravenous Injection, Solution by Auromedics Pharma LLC
  • More related products ...

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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.