NDC 0074-3109

Gengraf

Cyclosporine

Gengraf is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Abbvie Inc.. The primary component is Cyclosporine.

• Product ID: 0074-3109_4abab0be-cf15-0095-c5ad-fcc3bf039d4f
• NDC: 0074-3109
• Product Type: Human Prescription Drug
• Proprietary Name: Gengraf
• Generic Name: Cyclosporine
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2015-11-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA065003
• Labeler Name: AbbVie Inc.
• Substance Name: CYCLOSPORINE
• Active Ingredient Strength: 100 mg/1
• 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: 2021-12-31

Packaging

NDC 0074-3109-32

5 BLISTER PACK in 1 CARTON (0074-3109-32) > 6 CAPSULE in 1 BLISTER PACK

• Marketing Start Date: 2015-11-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0074-3109-32 [00074310932]

Gengraf CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA065003
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2015-11-01

Drug Details

Active Ingredients

Ingredient	Strength
CYCLOSPORINE	100 mg/1

OpenFDA Data

• SPL SET ID: e896cbfe-4745-4088-82a3-8dc10b75c41f
• Manufacturer:
  • AbbVie Inc.
• UNII:
  • 83HN0GTJ6D
• RxNorm Concept Unique ID - RxCUI:
  • 1797521
  • 835925
  • 241834
  • 835894
  • 835835
  • 835896

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
0078-0109	Sandimmune	cyclosporine
0078-0110	Sandimmune	cyclosporine
0078-0240	Sandimmune	cyclosporine
0078-0241	Sandimmune	cyclosporine