NDC 0078-0414

Zortress

Everolimus

Zortress is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Everolimus.

• Product ID: 0078-0414_003fbaa6-1698-4767-9222-2e5735085502
• NDC: 0078-0414
• Product Type: Human Prescription Drug
• Proprietary Name: Zortress
• Generic Name: Everolimus
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2010-04-22
• Marketing Category: NDA / NDA
• Application Number: NDA021560
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: EVEROLIMUS
• Active Ingredient Strength: 1 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: 2019-12-31

Packaging

NDC 0078-0414-20

60 BLISTER PACK in 1 BOX (0078-0414-20) > 1 TABLET in 1 BLISTER PACK (0078-0414-61)

• Marketing Start Date: 2010-04-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0414-20 [00078041420]

Zortress TABLET

• Marketing Category: NDA
• Application Number: NDA021560
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-04-22

NDC 0078-0414-61 [00078041461]

Zortress TABLET

• Marketing Category: NDA
• Application Number: NDA021560
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2010-04-22

Drug Details

Active Ingredients

Ingredient	Strength
EVEROLIMUS	.5 mg/1

OpenFDA Data

• SPL SET ID: e082a024-7850-400b-a5c2-2a140612562a
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 9HW64Q8G6G
• RxNorm Concept Unique ID - RxCUI:
  • 2056895
  • 2056897
  • 977438
  • 977427
  • 977431
  • 977436
  • 977434
  • 977440

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 "Zortress" or generic name "Everolimus"

NDC	Brand Name	Generic Name
0078-0414	Zortress	everolimus
0078-0415	Zortress	everolimus
0078-0417	Zortress	everolimus
0078-0422	Zortress	everolimus
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