NDC 0078-0468

Exjade

Deferasirox

Exjade is a Oral Tablet, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Deferasirox.

• Product ID: 0078-0468_12e80115-bfb7-4292-89cc-e696a3c6c325
• NDC: 0078-0468
• Product Type: Human Prescription Drug
• Proprietary Name: Exjade
• Generic Name: Deferasirox
• Dosage Form: Tablet, For Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2005-11-30
• Marketing Category: NDA / NDA
• Application Number: NDA021882
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: DEFERASIROX
• Active Ingredient Strength: 125 mg/1
• Pharm Classes: Iron Chelating Activity [MoA],Iron Chelator [EPC],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Cytochrome P450 1A2 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 0078-0468-15

30 TABLET, FOR SUSPENSION in 1 BOTTLE (0078-0468-15)

• Marketing Start Date: 2005-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0468-15 [00078046815]

Exjade TABLET, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA021882
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-11-30

Drug Details

Active Ingredients

Ingredient	Strength
DEFERASIROX	125 mg/1

OpenFDA Data

• SPL SET ID: 3495a70c-870c-4968-940e-8baea152cf85
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • V8G4MOF2V9
• RxNorm Concept Unique ID - RxCUI:
  • 597768
  • 597772
  • 597770
  • 616161
  • 616163
  • 616159

Pharmacological Class

• Iron Chelating Activity [MoA]
• Iron Chelator [EPC]
• Cytochrome P450 3A4 Inducers [MoA]
• Cytochrome P450 2C8 Inhibitors [MoA]
• Cytochrome P450 1A2 Inhibitors [MoA]

NDC Crossover Matching brand name "Exjade" or generic name "Deferasirox"

NDC	Brand Name	Generic Name
0078-0468	Exjade	deferasirox
0078-0469	Exjade	deferasirox
0078-0470	Exjade	deferasirox
0078-0654	Jadenu	deferasirox
0078-0655	Jadenu	deferasirox
0078-0656	Jadenu	deferasirox