restasis

Generic: cyclosporine

Labeler: allergan, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name restasis
Generic Name cyclosporine
Labeler allergan, inc.
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

cyclosporine .5 mg/mL

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0023-9163
Product ID 0023-9163_3b350ae7-28e6-4dbd-824c-d0fe46b81e5a
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 00239163
Hyphenated Format 0023-9163

Supplemental Identifiers

RxCUI
2572292 2572293
UNII
83HN0GTJ6D
NUI
N0000175457 N0000175458 N0000182141 N0000185503

Packaging Origin

Original Packager
true

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
  • 5 VIAL, SINGLE-USE in 1 CARTON (0023-9163-12) / .4 mL in 1 VIAL, SINGLE-USE
  • 30 VIAL, SINGLE-USE in 1 TRAY (0023-9163-30) / .4 mL in 1 VIAL, SINGLE-USE
  • 60 VIAL, SINGLE-USE in 1 TRAY (0023-9163-60) / .4 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (3)

0023-9163-12 5 VIAL, SINGLE-USE in 1 CARTON (0023-9163-12) / .4 mL in 1 VIAL, SINGLE-USE 0023-9163-30 30 VIAL, SINGLE-USE in 1 TRAY (0023-9163-30) / .4 mL in 1 VIAL, SINGLE-USE 0023-9163-60 60 VIAL, SINGLE-USE in 1 TRAY (0023-9163-60) / .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": "3b350ae7-28e6-4dbd-824c-d0fe46b81e5a", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["2572292", "2572293"], "spl_set_id": ["8e24af2b-bc1c-4849-94f2-6df950cdca89"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Allergan, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "5 VIAL, SINGLE-USE in 1 CARTON (0023-9163-12)  / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0023-9163-12", "marketing_start_date": "20030401"}, {"sample": false, "description": "30 VIAL, SINGLE-USE in 1 TRAY (0023-9163-30)  / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0023-9163-30", "marketing_start_date": "20030401"}, {"sample": false, "description": "60 VIAL, SINGLE-USE in 1 TRAY (0023-9163-60)  / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0023-9163-60", "marketing_start_date": "20030401"}], "brand_name": "RESTASIS", "product_id": "0023-9163_3b350ae7-28e6-4dbd-824c-d0fe46b81e5a", "dosage_form": "EMULSION", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0023-9163", "generic_name": "cyclosporine", "labeler_name": "Allergan, Inc.", "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"}