sandimmune

Generic: cyclosporine

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name sandimmune
Generic Name cyclosporine
Labeler novartis pharmaceuticals corporation
Dosage Form CAPSULE, LIQUID FILLED
Routes
ORAL
Active Ingredients

cyclosporine 100 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0241
Product ID 0078-0241_a95916e5-4d66-4009-a36c-9ca9e6ce6867
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050625
Listing Expiration 2026-12-31
Marketing Start 1990-03-02

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 00780241
Hyphenated Format 0078-0241

Supplemental Identifiers

RxCUI
197552 197553 205175 212810 212844 212957 309632 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 sandimmune (source: ndc)
Generic Name cyclosporine (source: ndc)
Application Number NDA050625 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 PACKAGE (0078-0241-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0241-61)
source: ndc

Packages (1)

0078-0241-15 30 BLISTER PACK in 1 PACKAGE (0078-0241-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0241-61)

Ingredients (1)

cyclosporine (100 mg/1)

Linked Drug Pages (1)

Sandimmune ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "a95916e5-4d66-4009-a36c-9ca9e6ce6867", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["197552", "197553", "205175", "212810", "212844", "212957", "309632", "328160"], "spl_set_id": ["5e5926a7-1de0-4b54-a5c0-286b6200ff82"], "pharm_class_epc": ["Calcineurin Inhibitor Immunosuppressant [EPC]"], "pharm_class_moa": ["Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 PACKAGE (0078-0241-15)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0241-61)", "package_ndc": "0078-0241-15", "marketing_start_date": "19900302"}], "brand_name": "Sandimmune", "product_id": "0078-0241_a95916e5-4d66-4009-a36c-9ca9e6ce6867", "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": "0078-0241", "generic_name": "cyclosporine", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sandimmune", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": "100 mg/1"}], "application_number": "NDA050625", "marketing_category": "NDA", "marketing_start_date": "19900302", "listing_expiration_date": "20261231"}