NDC 0078-0683

Arranon

Nelarabine

Arranon is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Nelarabine.

• Product ID: 0078-0683_3616a9ae-3037-42aa-825f-78628639e3e9
• NDC: 0078-0683
• Product Type: Human Prescription Drug
• Proprietary Name: Arranon
• Generic Name: Nelarabine
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-10-05
• Marketing Category: NDA / NDA
• Application Number: NDA021877
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: NELARABINE
• Active Ingredient Strength: 5 mg/mL
• Pharm Classes: Nucleoside Metabolic Inhibitor [EPC],Nucleic Acid Synthesis Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0078-0683-06

6 VIAL in 1 CARTON (0078-0683-06) > 50 mL in 1 VIAL

• Marketing Start Date: 2016-10-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0683-06 [00078068306]

Arranon INJECTION

• Marketing Category: NDA
• Application Number: NDA021877
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-10-05

NDC 0078-0683-61 [00078068361]

Arranon INJECTION

• Marketing Category: NDA
• Application Number: NDA021877
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-08-02

Drug Details

Active Ingredients

Ingredient	Strength
NELARABINE	5 mg/mL

OpenFDA Data

• SPL SET ID: fffa5d75-0dba-4ad7-a252-5f60fa28489a
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 60158CV180
• RxNorm Concept Unique ID - RxCUI:
  • 603566
  • 616366

Pharmacological Class

• Nucleoside Metabolic Inhibitor [EPC]
• Nucleic Acid Synthesis Inhibitors [MoA]

NDC Crossover Matching brand name "Arranon" or generic name "Nelarabine"

NDC	Brand Name	Generic Name
0078-0683	Arranon	nelarabine
43598-142	Nelarabine	Nelarabine
70710-1726	Nelarabine	Nelarabine
70710-1839	Nelarabine	Nelarabine
70771-1685	Nelarabine	Nelarabine