NDC 50090-1242

RESTASIS

Cyclosporine

RESTASIS is a Ophthalmic Emulsion in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Cyclosporine.

• Product ID: 50090-1242_2af9d19d-a029-4d25-9d01-99e7caf324a8
• NDC: 50090-1242
• Product Type: Human Prescription Drug
• Proprietary Name: RESTASIS
• Generic Name: Cyclosporine
• Dosage Form: Emulsion
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2003-04-01
• Marketing Category: NDA / NDA
• Application Number: NDA050790
• Labeler Name: A-S Medication Solutions
• 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: 2022-12-31

Packaging

NDC 50090-1242-0

30 VIAL, SINGLE-USE in 1 TRAY (50090-1242-0) > .4 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2014-11-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-1242-0 [50090124200]

RESTASIS EMULSION

• Marketing Category: NDA
• Application Number: NDA050790
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-11-28
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-02-14

Drug Details

Active Ingredients

Ingredient	Strength
CYCLOSPORINE	.5 mg/mL

OpenFDA Data

• SPL SET ID: ce9325ab-fca1-4dae-8e53-a46ec95d3a76
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • 83HN0GTJ6D
• RxNorm Concept Unique ID - RxCUI:
  • 402092
  • 351291

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
0023-9163	RESTASIS	cyclosporine
50090-1242	RESTASIS	RESTASIS
50090-4476	RESTASIS	RESTASIS
0074-3108	Gengraf	Cyclosporine
0074-3109	Gengraf	Cyclosporine
0074-7269	Gengraf	Cyclosporine
0078-0246	Neoral	cyclosporine
0078-0248	Neoral	cyclosporine
0023-5301	Restasis MultiDose	cyclosporine
0078-0109	Sandimmune	cyclosporine
0078-0110	Sandimmune	cyclosporine
0078-0240	Sandimmune	cyclosporine
0078-0241	Sandimmune	cyclosporine