NDC 0078-0274

Neoral

Cyclosporine

Neoral is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Cyclosporine.

• Product ID: 0078-0274_06576850-10a7-4bc8-a8e4-2605b40448e4
• NDC: 0078-0274
• Product Type: Human Prescription Drug
• Proprietary Name: Neoral
• Generic Name: Cyclosporine
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 1995-07-14
• Marketing Category: NDA / NDA
• Application Number: NDA050716
• Labeler Name: Novartis Pharmaceuticals Corporation
• Substance Name: CYCLOSPORINE
• Active Ingredient Strength: 100 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: 2023-12-31

Packaging

NDC 0078-0274-22

1 BOTTLE in 1 CARTON (0078-0274-22) > 50 mL in 1 BOTTLE

• Marketing Start Date: 1995-07-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0078-0274-22 [00078027422]

Neoral SOLUTION

• Marketing Category: NDA
• Application Number: NDA050716
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1995-07-14

Drug Details

Active Ingredients

Ingredient	Strength
CYCLOSPORINE	100 mg/mL

OpenFDA Data

• SPL SET ID: 94461af3-11f1-4670-95d4-2965b9538ae3
• Manufacturer:
  • Novartis Pharmaceuticals Corporation
• UNII:
  • 83HN0GTJ6D
• RxNorm Concept Unique ID - RxCUI:
  • 835911
  • 835899
  • 835909
  • 835886
  • 835894
  • 241834

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0078-0246	Neoral	cyclosporine
0078-0248	Neoral	cyclosporine
0078-0274	Neoral	Neoral
0074-3108	Gengraf	Cyclosporine
0074-3109	Gengraf	Cyclosporine
0074-7269	Gengraf	Cyclosporine
0023-9163	RESTASIS	cyclosporine
0023-5301	Restasis MultiDose	cyclosporine
0078-0109	Sandimmune	cyclosporine
0078-0110	Sandimmune	cyclosporine
0078-0240	Sandimmune	cyclosporine
0078-0241	Sandimmune	cyclosporine