NDC 47335-507

CEQUA

Cyclosporine

CEQUA is a Ophthalmic; Topical Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Cyclosporine.

• Product ID: 47335-507_11d6e74c-6667-4c6f-80fd-59dfa881f316
• NDC: 47335-507
• Product Type: Human Prescription Drug
• Proprietary Name: CEQUA
• Generic Name: Cyclosporine
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC; TOPICAL
• Marketing Start Date: 2018-08-15
• Marketing Category: NDA / NDA
• Application Number: NDA210913
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: CYCLOSPORINE
• Active Ingredient Strength: 0 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 47335-507-97

1 POUCH in 1 BOX (47335-507-97) > 10 VIAL, SINGLE-DOSE in 1 POUCH > .25 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2018-08-15
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 47335-507-97 [47335050797]

CEQUA SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA210913
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-08-15

Drug Details

Active Ingredients

Ingredient	Strength
CYCLOSPORINE	.0009 mg/mL

OpenFDA Data

• SPL SET ID: 48c3d8a3-4289-4b52-9189-58b48596095c
• Manufacturer:
  • Sun Pharmaceutical Industries, Inc.
• UNII:
  • 83HN0GTJ6D
• RxNorm Concept Unique ID - RxCUI:
  • 2055021
  • 2055026

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
47335-506	CEQUA	CEQUA
47335-507	CEQUA	CEQUA
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