NDC 0078-0109

Sandimmune

Cyclosporine

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

• Product ID: 0078-0109_1e8368df-ba5b-49ad-8efa-a8814b91e186
• NDC: 0078-0109
• Product Type: Human Prescription Drug
• Proprietary Name: Sandimmune
• Generic Name: Cyclosporine
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1983-11-14
• Marketing Category: NDA / NDA
• Application Number: NDA050573
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: CYCLOSPORINE
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Calcineurin Inhibitor Immunosuppressant [EPC],Calcineurin Inhibitors [MoA],Cytochrome P450 3A4 Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0078-0109-01

10 AMPULE in 1 BOX (0078-0109-01) > 5 mL in 1 AMPULE (0078-0109-61)

• Marketing Start Date: 1983-11-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0109-01 [00078010901]

Sandimmune INJECTION

• Marketing Category: NDA
• Application Number: NDA050573
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1983-11-14

NDC 0078-0109-61 [00078010961]

Sandimmune INJECTION

• Marketing Category: NDA
• Application Number: NDA050573
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2012-08-10

Drug Details

Active Ingredients

Ingredient	Strength
CYCLOSPORINE	50 mg/mL

OpenFDA Data

• SPL SET ID: 5e5926a7-1de0-4b54-a5c0-286b6200ff82
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 83HN0GTJ6D
• RxNorm Concept Unique ID - RxCUI:
  • 205175
  • 197553
  • 197552
  • 212844
  • 212957
  • 212810
  • 309632
  • 328160

Pharmacological Class

• Calcineurin Inhibitor Immunosuppressant [EPC]
• Calcineurin Inhibitors [MoA]
• Cytochrome P450 3A4 Inhibitors [MoA]
• P-Glycoprotein Inhibitors [MoA]

NDC Crossover Matching brand name "Sandimmune" or generic name "Cyclosporine"

NDC	Brand Name	Generic Name
0078-0109	Sandimmune	cyclosporine
0078-0110	Sandimmune	cyclosporine
0078-0240	Sandimmune	cyclosporine
0078-0241	Sandimmune	cyclosporine
0074-3108	Gengraf	Cyclosporine
0074-3109	Gengraf	Cyclosporine
0074-7269	Gengraf	Cyclosporine
0078-0246	Neoral	cyclosporine
0078-0248	Neoral	cyclosporine
0023-9163	RESTASIS	cyclosporine
0023-5301	Restasis MultiDose	cyclosporine