cyclosporine

Generic: cyclosporine

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name cyclosporine
Generic Name cyclosporine
Labeler lupin pharmaceuticals, inc.
Dosage Form EMULSION
Routes
OPHTHALMIC
Active Ingredients

cyclosporine .5 mg/mL

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-214
Product ID 68180-214_3dade5e6-5243-42a1-b1fa-0fb094e8da5f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050790
Listing Expiration 2026-12-31
Marketing Start 2022-05-11

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 68180214
Hyphenated Format 68180-214

Supplemental Identifiers

RxCUI
2572292
UPC
0368180214601 0368180214304
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 (68180-214-30) / .4 mL in 1 VIAL, SINGLE-USE
  • 60 VIAL, SINGLE-USE in 1 TRAY (68180-214-60) / .4 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

68180-214-30 30 VIAL, SINGLE-USE in 1 TRAY (68180-214-30) / .4 mL in 1 VIAL, SINGLE-USE 68180-214-60 60 VIAL, SINGLE-USE in 1 TRAY (68180-214-60) / .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": "3dade5e6-5243-42a1-b1fa-0fb094e8da5f", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "upc": ["0368180214601", "0368180214304"], "unii": ["83HN0GTJ6D"], "rxcui": ["2572292"], "spl_set_id": ["9aca2026-af86-4e97-925e-c202b87c46ac"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 VIAL, SINGLE-USE in 1 TRAY (68180-214-30)  / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "68180-214-30", "marketing_start_date": "20220511"}, {"sample": false, "description": "60 VIAL, SINGLE-USE in 1 TRAY (68180-214-60)  / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "68180-214-60", "marketing_start_date": "20220511"}], "brand_name": "CYCLOSPORINE", "product_id": "68180-214_3dade5e6-5243-42a1-b1fa-0fb094e8da5f", "dosage_form": "EMULSION", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "68180-214", "generic_name": "cyclosporine", "labeler_name": "Lupin Pharmaceuticals, 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": "20220511", "listing_expiration_date": "20261231"}