NDC 0078-0673

HYCAMTIN

Topotecan

HYCAMTIN is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Topotecan Hydrochloride.

• Product ID: 0078-0673_56747dfc-1ff8-4f86-82e8-4c96e897a147
• NDC: 0078-0673
• Product Type: Human Prescription Drug
• Proprietary Name: HYCAMTIN
• Generic Name: Topotecan
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2017-02-24
• Marketing Category: NDA / NDA
• Application Number: NDA020981
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: TOPOTECAN HYDROCHLORIDE
• Active Ingredient Strength: 1 mg/1
• Pharm Classes: Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0078-0673-01

10 CAPSULE in 1 BOTTLE (0078-0673-01)

• Marketing Start Date: 2017-02-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0673-01 [00078067301]

HYCAMTIN CAPSULE

• Marketing Category: NDA
• Application Number: NDA020981
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-02-24

Drug Details

Active Ingredients

Ingredient	Strength
TOPOTECAN HYDROCHLORIDE	1 mg/1

OpenFDA Data

• SPL SET ID: aa0815bb-8916-4c2c-9201-b04eb78e91fa
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 956S425ZCY
• RxNorm Concept Unique ID - RxCUI:
  • 747195
  • 748740
  • 748738
  • 747193

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0078-0672	HYCAMTIN	topotecan
0078-0673	HYCAMTIN	topotecan
0078-0674	HYCAMTIN	topotecan hydrochloride
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