NDC 0703-4685

mitoXANTRONE

Mitoxantrone

mitoXANTRONE is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Teva Parenteral Medicines, Inc.. The primary component is Mitoxantrone Hydrochloride.

• Product ID: 0703-4685_031f9934-217e-40c4-b623-92a44b5831ac
• NDC: 0703-4685
• Product Type: Human Prescription Drug
• Proprietary Name: mitoXANTRONE
• Generic Name: Mitoxantrone
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2006-04-11
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077356
• Labeler Name: Teva Parenteral Medicines, Inc.
• Substance Name: MITOXANTRONE HYDROCHLORIDE
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0703-4685-01

1 VIAL, MULTI-DOSE in 1 CARTON (0703-4685-01) > 10 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2006-04-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0703-4685-01 [00703468501]

mitoXANTRONE INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA077356
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2006-04-11

Drug Details

Active Ingredients

Ingredient	Strength
MITOXANTRONE HYDROCHLORIDE	2 mg/mL

OpenFDA Data

• SPL SET ID: 4d0f0f1a-31af-40fa-9c64-e90891fa6ce4
• Manufacturer:
  • Teva Parenteral Medicines, Inc.
• UNII:
  • U6USW86RD0
• RxNorm Concept Unique ID - RxCUI:
  • 197989
• UPC Code:
  • 0307034680018
  • 0307034685013

Pharmacological Class

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

NDC Crossover Matching brand name "mitoXANTRONE" or generic name "Mitoxantrone"

NDC	Brand Name	Generic Name
0703-4680	mitoXANTRONE	mitoXANTRONE
0703-4685	mitoXANTRONE	mitoXANTRONE
0703-4686	mitoXANTRONE	mitoXANTRONE
61703-343	Mitoxantrone	Mitoxantrone
63323-132	Mitoxantrone	MITOXANTRONE HYDROCHLORIDE