NDC 69097-262

TOPOTECAN HYDROCHLORIDE

Topotecan Hydrochloride

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

• Product ID: 69097-262_4e757b90-6761-4586-914f-6bc194402399
• NDC: 69097-262
• Product Type: Human Prescription Drug
• Proprietary Name: TOPOTECAN HYDROCHLORIDE
• Generic Name: Topotecan Hydrochloride
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2010-12-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA091199
• Labeler Name: Cipla USA Inc.
• 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 69097-262-67

1 VIAL, SINGLE-DOSE in 1 CARTON (69097-262-67) > 4 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2010-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69097-262-67 [69097026267]

TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA091199
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-12-01

NDC 69097-262-68 [69097026268]

TOPOTECAN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA091199
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-12-01

Drug Details

Active Ingredients

Ingredient	Strength
TOPOTECAN HYDROCHLORIDE	4 mg/4mL

OpenFDA Data

• SPL SET ID: dd90b707-73c7-4d71-8d23-1ebbae251da1
• Manufacturer:
  • Cipla USA Inc.
• UNII:
  • 956S425ZCY
• RxNorm Concept Unique ID - RxCUI:
  • 1799416

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
0078-0674	HYCAMTIN	topotecan hydrochloride
71288-127	Topotecan	Topotecan Hydrochloride