NDC 0078-0713

Jadenu

Deferasirox

Jadenu is a Oral Granule in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Deferasirox.

• Product ID: 0078-0713_19ac4728-bb03-46b7-8221-28c2a43bc913
• NDC: 0078-0713
• Product Type: Human Prescription Drug
• Proprietary Name: Jadenu
• Generic Name: Deferasirox
• Dosage Form: Granule
• Route of Administration: ORAL
• Marketing Start Date: 2017-05-18
• Marketing Category: NDA / NDA
• Application Number: NDA207968
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: DEFERASIROX
• Active Ingredient Strength: 180 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 0078-0713-15

30 PACKET in 1 CARTON (0078-0713-15) > 1 GRANULE in 1 PACKET (0078-0713-19)

• Marketing Start Date: 2017-05-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0713-15 [00078071315]

Jadenu GRANULE

• Marketing Category: NDA
• Application Number: NDA207968
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-05-18

NDC 0078-0713-19 [00078071319]

Jadenu GRANULE

• Marketing Category: NDA
• Application Number: NDA207968
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-05-18

Drug Details

Active Ingredients

Ingredient	Strength
DEFERASIROX	180 mg/1

OpenFDA Data

• SPL SET ID: fee89140-fff1-4443-9f42-24ac004fcda1
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • V8G4MOF2V9
• RxNorm Concept Unique ID - RxCUI:
  • 1923829
  • 1923825
  • 1923828
  • 1607790
  • 1607792
  • 1607794
  • 1607796
  • 1607798
  • 1607784
  • 1923822
  • 1923826
  • 1923827

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 "Jadenu" or generic name "Deferasirox"

NDC	Brand Name	Generic Name
0078-0654	Jadenu	deferasirox
0078-0655	Jadenu	deferasirox
0078-0656	Jadenu	deferasirox
0078-0713	Jadenu	Jadenu
0078-0720	Jadenu	Jadenu
0078-0727	Jadenu	Jadenu
0078-0468	Exjade	deferasirox
0078-0469	Exjade	deferasirox
0078-0470	Exjade	deferasirox