cyclosporine

Generic: cyclosporine

Labeler: teva pharmaceuticals usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclosporine
Generic Name cyclosporine
Labeler teva pharmaceuticals usa, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cyclosporine 100 mg/mL

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0172-7313
Product ID 0172-7313_94a2cdae-e60e-47c4-8bca-8baac9f21b33
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065078
Listing Expiration 2026-12-31
Marketing Start 2005-03-29

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 01727313
Hyphenated Format 0172-7313

Supplemental Identifiers

RxCUI
835886
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 ANDA065078 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 PACKAGE (0172-7313-20) / 50 mL in 1 BOTTLE
source: ndc

Packages (1)

0172-7313-20 1 BOTTLE in 1 PACKAGE (0172-7313-20) / 50 mL in 1 BOTTLE

Ingredients (1)

cyclosporine (100 mg/mL)

Linked Drug Pages (1)

Cyclosporine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "94a2cdae-e60e-47c4-8bca-8baac9f21b33", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["835886"], "spl_set_id": ["f3dc2a50-1084-4190-a6f3-37034a04db86"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 PACKAGE (0172-7313-20)  / 50 mL in 1 BOTTLE", "package_ndc": "0172-7313-20", "marketing_start_date": "20050329"}], "brand_name": "Cyclosporine", "product_id": "0172-7313_94a2cdae-e60e-47c4-8bca-8baac9f21b33", "dosage_form": "SOLUTION", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0172-7313", "generic_name": "Cyclosporine", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclosporine", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": "100 mg/mL"}], "application_number": "ANDA065078", "marketing_category": "ANDA", "marketing_start_date": "20050329", "listing_expiration_date": "20261231"}