cyclosporine

Generic: cyclosporine

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

Drug Facts

Product Profile

Brand Name cyclosporine
Generic Name cyclosporine
Labeler apotex corp.
Dosage Form CAPSULE, GELATIN COATED
Routes
ORAL
Active Ingredients

cyclosporine 100 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-0134
Product ID 60505-0134_aa39e91b-f23e-69c8-e400-1f896c77b8e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065040
Listing Expiration 2026-12-31
Marketing Start 2002-05-29

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 605050134
Hyphenated Format 60505-0134

Supplemental Identifiers

RxCUI
197553 328160
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 ANDA065040 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-0134-0)
source: ndc

Packages (1)

60505-0134-0 30 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-0134-0)

Ingredients (1)

cyclosporine (100 mg/1)

Linked Drug Pages (1)

Cyclosporine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "aa39e91b-f23e-69c8-e400-1f896c77b8e2", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["197553", "328160"], "spl_set_id": ["bfca7088-fe93-abb9-3ec3-e6f5710a69c6"], "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 CAPSULE, GELATIN COATED in 1 BOTTLE (60505-0134-0)", "package_ndc": "60505-0134-0", "marketing_start_date": "20020529"}], "brand_name": "Cyclosporine", "product_id": "60505-0134_aa39e91b-f23e-69c8-e400-1f896c77b8e2", "dosage_form": "CAPSULE, GELATIN COATED", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "60505-0134", "generic_name": "Cyclosporine", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclosporine", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": "100 mg/1"}], "application_number": "ANDA065040", "marketing_category": "ANDA", "marketing_start_date": "20020529", "listing_expiration_date": "20261231"}