NDC 0078-0674

HYCAMTIN

Topotecan Hydrochloride

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

• Product ID: 0078-0674_1178da09-0d58-4e32-a819-e621a98215bf
• NDC: 0078-0674
• Product Type: Human Prescription Drug
• Proprietary Name: HYCAMTIN
• Generic Name: Topotecan Hydrochloride
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-12-21
• Marketing Category: NDA / NDA
• Application Number: NDA020671
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: TOPOTECAN HYDROCHLORIDE
• Active Ingredient Strength: 4 mg/4mL
• Pharm Classes: Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0078-0674-61

1 VIAL, SINGLE-DOSE in 1 CARTON (0078-0674-61) > 4 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2016-12-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0674-61 [00078067461]

HYCAMTIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020671
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-12-21

Drug Details

Active Ingredients

Ingredient	Strength
TOPOTECAN HYDROCHLORIDE	4 mg/4mL

OpenFDA Data

• SPL SET ID: eeee060c-a9ec-423e-a374-8484009f8524
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 956S425ZCY
• RxNorm Concept Unique ID - RxCUI:
  • 1799416
  • 637550

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0078-0672	HYCAMTIN	topotecan
0078-0673	HYCAMTIN	topotecan
0078-0674	HYCAMTIN	topotecan hydrochloride
71288-127	Topotecan	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
69097-262	TOPOTECAN HYDROCHLORIDE	TOPOTECAN HYDROCHLORIDE