cyclosporine

Generic: cyclosporine

Labeler: kvk-tech, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name cyclosporine
Generic Name cyclosporine
Labeler kvk-tech, inc.
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

cyclosporine .5 mg/mL

Manufacturer
KVK-TECH, INC.

Identifiers & Regulatory

Product NDC 10702-808
Product ID 10702-808_795f036f-ee97-42b7-bd36-fff9220ce428
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050790
Listing Expiration 2026-12-31
Marketing Start 2022-02-10

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 10702808
Hyphenated Format 10702-808

Supplemental Identifiers

RxCUI
2572292
UPC
0310702808034 0310702808065
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 cyclosporine (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 (10702-808-03) / .4 mL in 1 VIAL, SINGLE-USE
  • 60 VIAL, SINGLE-USE in 1 TRAY (10702-808-06) / .4 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

10702-808-03 30 VIAL, SINGLE-USE in 1 TRAY (10702-808-03) / .4 mL in 1 VIAL, SINGLE-USE 10702-808-06 60 VIAL, SINGLE-USE in 1 TRAY (10702-808-06) / .4 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

cyclosporine (.5 mg/mL)

Linked Drug Pages (1)

Cyclosporine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "795f036f-ee97-42b7-bd36-fff9220ce428", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "upc": ["0310702808034", "0310702808065"], "unii": ["83HN0GTJ6D"], "rxcui": ["2572292"], "spl_set_id": ["a7040dc6-063b-40ee-8f2a-153e87b08430"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["KVK-TECH, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 VIAL, SINGLE-USE in 1 TRAY (10702-808-03)  / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "10702-808-03", "marketing_start_date": "20220210"}, {"sample": false, "description": "60 VIAL, SINGLE-USE in 1 TRAY (10702-808-06)  / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "10702-808-06", "marketing_start_date": "20220210"}], "brand_name": "Cyclosporine", "product_id": "10702-808_795f036f-ee97-42b7-bd36-fff9220ce428", "dosage_form": "EMULSION", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "10702-808", "generic_name": "Cyclosporine", "labeler_name": "KVK-TECH, INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclosporine", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": ".5 mg/mL"}], "application_number": "NDA050790", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20220210", "listing_expiration_date": "20261231"}