cyclosporine, modfied

Generic: cyclosporine

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclosporine, modfied
Generic Name cyclosporine
Labeler apotex corp.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

cyclosporine 25 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4630
Product ID 60505-4630_5cee848b-4ce1-07e1-419d-8664662517d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210721
Listing Expiration 2026-12-31
Marketing Start 2019-11-05

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 605054630
Hyphenated Format 60505-4630

Supplemental Identifiers

RxCUI
241834 835894 835925
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, modfied (source: ndc)
Generic Name cyclosporine (source: ndc)
Application Number ANDA210721 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (60505-4630-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
source: ndc

Packages (1)

60505-4630-3 30 BLISTER PACK in 1 CARTON (60505-4630-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Ingredients (1)

cyclosporine (25 mg/1)

Linked Drug Pages (1)

CycloSPORINE, Modfied ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5cee848b-4ce1-07e1-419d-8664662517d5", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["241834", "835894", "835925"], "spl_set_id": ["5baaf78c-90f6-abcf-52c8-814490f3cf9f"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (60505-4630-3)  / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK", "package_ndc": "60505-4630-3", "marketing_start_date": "20191105"}], "brand_name": "CycloSPORINE, Modfied", "product_id": "60505-4630_5cee848b-4ce1-07e1-419d-8664662517d5", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "60505-4630", "generic_name": "Cyclosporine", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CycloSPORINE, Modfied", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": "25 mg/1"}], "application_number": "ANDA210721", "marketing_category": "ANDA", "marketing_start_date": "20191105", "listing_expiration_date": "20261231"}