NDC 0023-9163

RESTASIS

Cyclosporine

RESTASIS 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: 0023-9163_07c93bd7-9cc1-4ab4-a71a-9f97e13b963c
• NDC: 0023-9163
• 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: 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: 2019-12-31

Packaging

NDC 0023-9163-12

5 VIAL, SINGLE-USE in 1 CARTON (0023-9163-12) > .4 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2003-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0023-9163-12 [00023916312]

RESTASIS EMULSION

• Marketing Category: NDA
• Application Number: NDA050790
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2003-04-01

NDC 0023-9163-30 [00023916330]

RESTASIS EMULSION

• Marketing Category: NDA
• Application Number: NDA050790
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-04-01

NDC 0023-9163-60 [00023916360]

RESTASIS EMULSION

• Marketing Category: NDA
• Application Number: NDA050790
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-04-01

NDC 0023-9163-32 [00023916332]

RESTASIS EMULSION

• Marketing Category: NDA
• Application Number: NDA050790
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2003-04-01
• Marketing End Date: 2009-12-31

Drug Details

Active Ingredients

Ingredient	Strength
CYCLOSPORINE	.5 mg/mL

OpenFDA Data

• SPL SET ID: 8e24af2b-bc1c-4849-94f2-6df950cdca89
• Manufacturer:
  • Allergan, Inc.
• UNII:
  • 83HN0GTJ6D
• RxNorm Concept Unique ID - RxCUI:
  • 402092
  • 351291
• UPC Code:
  • 0300239163607

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