NDC 0078-0628

Afinitor Disperz

Everolimus

Afinitor Disperz 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 Everolimus.

• Product ID: 0078-0628_0ced2a29-15c1-4c3a-b89c-777f1297918c
• NDC: 0078-0628
• Product Type: Human Prescription Drug
• Proprietary Name: Afinitor Disperz
• Generic Name: Everolimus
• Dosage Form: Tablet, For Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2012-08-29
• Marketing Category: NDA / NDA
• Application Number: NDA203985
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: EVEROLIMUS
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA],Cytochrome P450 2D6 Inhibitors [MoA],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Decreased Immunologic Activity [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0078-0628-51

28 BLISTER PACK in 1 CARTON (0078-0628-51) > 1 TABLET, FOR SUSPENSION in 1 BLISTER PACK (0078-0628-61)

• Marketing Start Date: 2012-08-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0628-61 [00078062861]

Afinitor Disperz TABLET, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA203985
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-08-29

NDC 0078-0628-51 [00078062851]

Afinitor Disperz TABLET, FOR SUSPENSION

• Marketing Category: NDA
• Application Number: NDA203985
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-08-29

Drug Details

Active Ingredients

Ingredient	Strength
EVEROLIMUS	5 mg/1

OpenFDA Data

• SPL SET ID: 2150f73a-179b-4afc-b8ce-67c85cc72f04
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 9HW64Q8G6G
• RxNorm Concept Unique ID - RxCUI:
  • 998189
  • 1119402
  • 845518
  • 845515
  • 845507
  • 845512
  • 1119400
  • 998191
  • 1308432
  • 1308430
  • 1310138
  • 1310147
  • 1310144
  • 1308428

Pharmacological Class

• Kinase Inhibitor [EPC]
• Protein Kinase Inhibitors [MoA]
• Cytochrome P450 3A4 Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]
• Cytochrome P450 2D6 Inhibitors [MoA]
• mTOR Inhibitor Immunosuppressant [EPC]
• mTOR Inhibitors [MoA]
• Decreased Immunologic Activity [PE]

NDC Crossover Matching brand name "Afinitor Disperz" or generic name "Everolimus"

NDC	Brand Name	Generic Name
0078-0628	Afinitor Disperz	Afinitor Disperz
0078-0626	Afinitor Disperz	Afinitor Disperz
0078-0627	Afinitor Disperz	Afinitor Disperz
0054-0470	Everolimus	Everolimus
0054-0471	Everolimus	Everolimus
0054-0472	Everolimus	Everolimus
0054-0480	Everolimus	Everolimus
0054-0481	Everolimus	Everolimus
0054-0482	Everolimus	Everolimus
0054-0497	Everolimus	Everolimus
0054-0604	Everolimus	Everolimus
0078-0414	Zortress	everolimus
0078-0415	Zortress	everolimus
0078-0417	Zortress	everolimus
0078-0422	Zortress	everolimus