cyclosporine modified

Generic: cyclosporine

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

Drug Facts

Product Profile

Brand Name cyclosporine modified
Generic Name cyclosporine
Labeler teva pharmaceuticals usa, inc.
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

cyclosporine 50 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-9019
Product ID 0093-9019_d5d977b4-fc80-4e46-ab55-280fd6d4ea12
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065110
Listing Expiration 2026-12-31
Marketing Start 2021-06-08

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 00939019
Hyphenated Format 0093-9019

Supplemental Identifiers

RxCUI
241834 835894 835925
UPC
0300939018658
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 modified (source: ndc)
Generic Name cyclosporine (source: ndc)
Application Number ANDA065110 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0093-9019-65) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0093-9019-19)
source: ndc

Packages (1)

0093-9019-65 30 BLISTER PACK in 1 CARTON (0093-9019-65) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0093-9019-19)

Ingredients (1)

cyclosporine (50 mg/1)

Linked Drug Pages (1)

Cyclosporine Modified ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "d5d977b4-fc80-4e46-ab55-280fd6d4ea12", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "upc": ["0300939018658"], "unii": ["83HN0GTJ6D"], "rxcui": ["241834", "835894", "835925"], "spl_set_id": ["2de1e8b1-625f-43ce-a1d5-d543be208b11"], "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": "30 BLISTER PACK in 1 CARTON (0093-9019-65)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0093-9019-19)", "package_ndc": "0093-9019-65", "marketing_start_date": "20210608"}], "brand_name": "Cyclosporine Modified", "product_id": "0093-9019_d5d977b4-fc80-4e46-ab55-280fd6d4ea12", "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": "0093-9019", "generic_name": "Cyclosporine", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclosporine", "brand_name_suffix": "Modified", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": "50 mg/1"}], "application_number": "ANDA065110", "marketing_category": "ANDA", "marketing_start_date": "20210608", "listing_expiration_date": "20261231"}