NDC 0023-5301

Restasis MultiDose

Cyclosporine

Restasis MultiDose is a Ophthalmic Emulsion in the Human Prescription Drug category. It is labeled and distributed by Allergan, Inc.. The primary component is Cyclosporine.

• Product ID: 0023-5301_e579186c-6dfc-41c3-9cc9-a32d36352507
• NDC: 0023-5301
• Product Type: Human Prescription Drug
• Proprietary Name: Restasis MultiDose
• Generic Name: Cyclosporine
• Dosage Form: Emulsion
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2016-11-10
• Marketing Category: NDA / NDA
• Application Number: NDA050790
• Labeler Name: Allergan, Inc.
• Substance Name: CYCLOSPORINE
• Active Ingredient Strength: 1 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 0023-5301-01

1 BOTTLE in 1 CARTON (0023-5301-01) > 1.5 mL in 1 BOTTLE

• Marketing Start Date: 2016-11-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0023-5301-05 [00023530105]

Restasis MultiDose EMULSION

• Marketing Category: NDA
• Application Number: NDA050790
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-11-10

NDC 0023-5301-01 [00023530101]

Restasis MultiDose EMULSION

• Marketing Category: NDA
• Application Number: NDA050790
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-11-10

Drug Details

Active Ingredients

Ingredient	Strength
CYCLOSPORINE	.5 mg/mL

OpenFDA Data

• SPL SET ID: 7224d810-bb96-4682-a942-3355e6e8061a
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • 83HN0GTJ6D
• RxNorm Concept Unique ID - RxCUI:
  • 402092
  • 351291
• UPC Code:
  • 0300235301058

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 "Restasis MultiDose" or generic name "Cyclosporine"

NDC	Brand Name	Generic Name
0023-5301	Restasis MultiDose	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
0078-0109	Sandimmune	cyclosporine
0078-0110	Sandimmune	cyclosporine
0078-0240	Sandimmune	cyclosporine
0078-0241	Sandimmune	cyclosporine