restasis multidose

Generic: cyclosporine

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

Drug Facts

Product Profile

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

cyclosporine .5 mg/mL

Manufacturer
Allergan, Inc.

Identifiers & Regulatory

Product NDC 0023-5301
Product ID 0023-5301_6b6704de-6a92-4d21-8cb5-fbd1c2f3c489
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050790
Listing Expiration 2026-12-31
Marketing Start 2016-11-10

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 00235301
Hyphenated Format 0023-5301

Supplemental Identifiers

RxCUI
351291 402092
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 multidose (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
  • 1 BOTTLE in 1 CARTON (0023-5301-05) / 5.5 mL in 1 BOTTLE
source: ndc

Packages (1)

0023-5301-05 1 BOTTLE in 1 CARTON (0023-5301-05) / 5.5 mL in 1 BOTTLE

Ingredients (1)

cyclosporine (.5 mg/mL)

Linked Drug Pages (1)

Restasis MultiDose ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "6b6704de-6a92-4d21-8cb5-fbd1c2f3c489", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["351291", "402092"], "spl_set_id": ["7224d810-bb96-4682-a942-3355e6e8061a"], "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": false, "description": "1 BOTTLE in 1 CARTON (0023-5301-05)  / 5.5 mL in 1 BOTTLE", "package_ndc": "0023-5301-05", "marketing_start_date": "20161110"}], "brand_name": "Restasis MultiDose", "product_id": "0023-5301_6b6704de-6a92-4d21-8cb5-fbd1c2f3c489", "dosage_form": "EMULSION", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0023-5301", "generic_name": "cyclosporine", "labeler_name": "Allergan, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Restasis MultiDose", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": ".5 mg/mL"}], "application_number": "NDA050790", "marketing_category": "NDA", "marketing_start_date": "20161110", "listing_expiration_date": "20261231"}