restasis

Generic: cyclosporine

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name restasis
Generic Name cyclosporine
Labeler a-s medication solutions
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

cyclosporine .5 mg/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4476
Product ID 50090-4476_0a22357f-0136-44d5-ab37-0a7d15287b30
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050790
Listing Expiration 2026-12-31
Marketing Start 2003-04-01

Pharmacologic Class

Established (EPC)
calcineurin inhibitor immunosuppressant [epc]
Mechanism of Action
calcineurin inhibitors [moa] cytochrome p450 3a4 inhibitors [moa] p-glycoprotein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500904476
Hyphenated Format 50090-4476

Supplemental Identifiers

RxCUI
2572292 2572293
UNII
83HN0GTJ6D
NUI
N0000175457 N0000175458 N0000182141 N0000185503

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name restasis (source: ndc)
Generic Name cyclosporine (source: ndc)
Application Number NDA050790 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 30 VIAL, SINGLE-USE in 1 TRAY (50090-4476-0) / .4 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

50090-4476-0 30 VIAL, SINGLE-USE in 1 TRAY (50090-4476-0) / .4 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

cyclosporine (.5 mg/mL)

Linked Drug Pages (1)

RESTASIS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "0a22357f-0136-44d5-ab37-0a7d15287b30", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["2572292", "2572293"], "spl_set_id": ["ee57c1c0-2fcd-4628-8e33-4e0a9dadcb03"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 VIAL, SINGLE-USE in 1 TRAY (50090-4476-0)  / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "50090-4476-0", "marketing_start_date": "20190826"}], "brand_name": "RESTASIS", "product_id": "50090-4476_0a22357f-0136-44d5-ab37-0a7d15287b30", "dosage_form": "EMULSION", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "50090-4476", "generic_name": "cyclosporine", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "RESTASIS", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": ".5 mg/mL"}], "application_number": "NDA050790", "marketing_category": "NDA", "marketing_start_date": "20030401", "listing_expiration_date": "20261231"}