cyclosporine

Generic: cyclosporine

Labeler: mylan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cyclosporine .5 mg/mL

Manufacturer
Mylan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 0378-8760
Product ID 0378-8760_da3fa070-b512-4568-871a-dc8d5a949d13
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205894
Listing Expiration 2026-12-31
Marketing Start 2022-02-03

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 03788760
Hyphenated Format 0378-8760

Supplemental Identifiers

RxCUI
2572292
UPC
0303788760587 0303788760914
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 ANDA205894 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
source: ndc
Packaging
  • 6 POUCH in 1 CARTON (0378-8760-58) / 5 VIAL, SINGLE-USE in 1 POUCH (0378-8760-98) / .4 mL in 1 VIAL, SINGLE-USE
  • 12 POUCH in 1 CARTON (0378-8760-91) / 5 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

0378-8760-58 6 POUCH in 1 CARTON (0378-8760-58) / 5 VIAL, SINGLE-USE in 1 POUCH (0378-8760-98) / .4 mL in 1 VIAL, SINGLE-USE 0378-8760-91 12 POUCH in 1 CARTON (0378-8760-91) / 5 VIAL, SINGLE-USE in 1 POUCH / .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": "da3fa070-b512-4568-871a-dc8d5a949d13", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "upc": ["0303788760587", "0303788760914"], "unii": ["83HN0GTJ6D"], "rxcui": ["2572292"], "spl_set_id": ["da3fa070-b512-4568-871a-dc8d5a949d13"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 POUCH in 1 CARTON (0378-8760-58)  / 5 VIAL, SINGLE-USE in 1 POUCH (0378-8760-98)  / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0378-8760-58", "marketing_start_date": "20220203"}, {"sample": false, "description": "12 POUCH in 1 CARTON (0378-8760-91)  / 5 VIAL, SINGLE-USE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0378-8760-91", "marketing_start_date": "20220203"}], "brand_name": "Cyclosporine", "product_id": "0378-8760_da3fa070-b512-4568-871a-dc8d5a949d13", "dosage_form": "EMULSION", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0378-8760", "generic_name": "cyclosporine", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclosporine", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": ".5 mg/mL"}], "application_number": "ANDA205894", "marketing_category": "ANDA", "marketing_start_date": "20220203", "listing_expiration_date": "20261231"}