63323-762 : Topotecan Hydrochloride 4 mg/4ml Intravenous Injection, Powder, Lyophilized, for Solution


NDC: 63323-762
Labeler: App Pharmaceuticals, LLC
Product Type: Human Prescription Drug
Drug Name:  Topotecan Hydrochloride
Dosage Form: Intravenous Injection, Powder, Lyophilized, for Solution
Application #: ANDA091089
Rev. Date: 


NDC Package Codes:

  • 63323-762-10: 1 VIAL IN 1 BOX (63323‑762‑10) > 4 ML IN 1 VIAL
  • 63323-762-17: 5 BOX IN 1 CARTON (63323‑762‑17) > 1 VIAL IN 1 BOX > 4 ML IN 1 VIAL
  • 63323-762-55: 1 VIAL IN 1 BOX (63323‑762‑55) > 4 ML IN 1 VIAL
  • 63323-762-57: 5 BOX IN 1 CARTON (63323‑762‑57) > 1 VIAL IN 1 BOX > 4 ML IN 1 VIAL
  • 63323-762-94: 1 VIAL IN 1 BOX (63323‑762‑94) > 4 ML IN 1 VIAL

Active Ingredients:

  • Topotecan Hydrochloride

Dosage Strength:

  • 4 mg/4mL

Pharmaceutical Classes:

  • Topoisomerase Inhibitor [EPC]
  • Topoisomerase Inhibitors [MoA]

Related Products:

Based on records with the same trade name.
  • 0069-0075 Topotecan Hydrochloride 4 mg/4ml Intravenous Injection, Powder, Lyophilized, for Solution by Pfizer Laboratories Div Pfizer Inc.
  • 16729-151 Topotecan Hydrochloride 4 mg/4ml Intravenous Injection, Powder, Lyophilized, for Solution by Accord Healthcare Inc.
  • 25021-206 Topotecan Hydrochloride 4 mg/4ml Intravenous Injection, Powder, Lyophilized, for Solution by Sagent Pharmaceuticals
  • 25021-824 Topotecan Hydrochloride 4 mg/4ml Intravenous Injection, Powder, Lyophilized, for Solution by Sagent Pharmaceuticals
  • 45963-615 Topotecan Hydrochloride 4 mg/4ml Intravenous Injection, Powder, Lyophilized, for Solution by Actavis Pharma, Inc.
  • 55390-370 Topotecan Hydrochloride 4 mg/4ml Intravenous Injection, Powder, Lyophilized, for Solution by Bedford Laboratories
  • 62756-023 Topotecan Hydrochloride 4 mg/4ml Intravenous Injection, Powder, Lyophilized, for Solution by Sun Pharmaceutical Industries Limited
  • 66435-410 Topotecan Hydrochloride 4 mg/4ml Intravenous Injection, Powder, for Solution by Three Rivers Pharmaceuticals, LLC.
  • 67457-474 Topotecan Hydrochloride 4 mg/ml Intravenous Injection, Powder, Lyophilized, for Solution by Mylan Institutional LLC
  • 69097-262 Topotecan Hydrochloride 4 mg/4ml Intravenous Injection, Powder, Lyophilized, for Solution by Cipla USA 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.