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 INJECTION
Routes
INTRAVENOUS
Active Ingredients

cyclosporine 50 mg/mL

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0109
Product ID 0078-0109_a95916e5-4d66-4009-a36c-9ca9e6ce6867
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050573
Listing Expiration 2026-12-31
Marketing Start 1983-11-14

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 00780109
Hyphenated Format 0078-0109

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 NDA050573 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 AMPULE in 1 BOX (0078-0109-01) / 5 mL in 1 AMPULE (0078-0109-61)
source: ndc

Packages (1)

0078-0109-01 10 AMPULE in 1 BOX (0078-0109-01) / 5 mL in 1 AMPULE (0078-0109-61)

Ingredients (1)

cyclosporine (50 mg/mL)

Linked Drug Pages (1)

Sandimmune ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "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": "10 AMPULE in 1 BOX (0078-0109-01)  / 5 mL in 1 AMPULE (0078-0109-61)", "package_ndc": "0078-0109-01", "marketing_start_date": "19831114"}], "brand_name": "Sandimmune", "product_id": "0078-0109_a95916e5-4d66-4009-a36c-9ca9e6ce6867", "dosage_form": "INJECTION", "pharm_class": ["Calcineurin Inhibitor Immunosuppressant [EPC]", "Calcineurin Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "0078-0109", "generic_name": "cyclosporine", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sandimmune", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": "50 mg/mL"}], "application_number": "NDA050573", "marketing_category": "NDA", "marketing_start_date": "19831114", "listing_expiration_date": "20261231"}