NDC 71288-127

Topotecan

Topotecan Hydrochloride

Topotecan is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Meitheal Pharmaceuticals Inc.. The primary component is Topotecan Hydrochloride.

• Product ID: 71288-127_06f2245d-e8d3-4436-bcfb-6df6123e8119
• NDC: 71288-127
• Product Type: Human Prescription Drug
• Proprietary Name: Topotecan
• Generic Name: Topotecan Hydrochloride
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-09-02
• Marketing Category: ANDA / ANDA
• Application Number: ANDA201166
• Labeler Name: Meitheal Pharmaceuticals Inc.
• Substance Name: TOPOTECAN HYDROCHLORIDE
• Active Ingredient Strength: 4 mg/15mL
• Pharm Classes: Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 71288-127-15

1 VIAL, SINGLE-DOSE in 1 CARTON (71288-127-15) > 15 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-09-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71288-127-15 [71288012715]

Topotecan INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA201166
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-02

Drug Details

Active Ingredients

Ingredient	Strength
TOPOTECAN HYDROCHLORIDE	4 mg/15mL

OpenFDA Data

• SPL SET ID: 207ee628-1a7a-4949-bab2-07b9d79b72a3
• Manufacturer:
  • Meitheal Pharmaceuticals Inc.
• UNII:
  • 956S425ZCY
• RxNorm Concept Unique ID - RxCUI:
  • 1799416

Pharmacological Class

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

NDC Crossover Matching brand name "Topotecan" or generic name "Topotecan Hydrochloride"

NDC	Brand Name	Generic Name
0409-0302	Topotecan	TOPOTECAN
0703-4714	Topotecan	Topotecan
16729-243	Topotecan	Topotecan
25021-236	topotecan	topotecan
50742-404	Topotecan	Topotecan
66758-051	Topotecan	Topotecan
67457-662	TOPOTECAN	TOPOTECAN
71288-127	Topotecan	Topotecan
0078-0672	HYCAMTIN	topotecan
0078-0673	HYCAMTIN	topotecan
0078-0674	HYCAMTIN	topotecan hydrochloride
16729-151	topotecan hydrochloride	topotecan hydrochloride
45963-615	Topotecan hydrochloride	Topotecan hydrochloride
55390-370	Topotecan Hydrochloride	Topotecan Hydrochloride
63323-762	Topotecan Hydrochloride	TOPOTECAN HYDROCHLORIDE