neoral

Generic: cyclosporine

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

Drug Facts

Product Profile

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

cyclosporine 25 mg/1

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0246
Product ID 0078-0246_df11902a-3b90-428d-80f5-d587be982b4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050715
Listing Expiration 2026-12-31
Marketing Start 1995-07-14

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 00780246
Hyphenated Format 0078-0246

Supplemental Identifiers

RxCUI
241834 835886 835894 835899 835909 835911
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 neoral (source: ndc)
Generic Name cyclosporine (source: ndc)
Application Number NDA050715 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0078-0246-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0246-61)
source: ndc

Packages (1)

0078-0246-15 30 BLISTER PACK in 1 CARTON (0078-0246-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0246-61)

Ingredients (1)

cyclosporine (25 mg/1)

Linked Drug Pages (1)

Neoral ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "df11902a-3b90-428d-80f5-d587be982b4c", "openfda": {"nui": ["N0000175457", "N0000175458", "N0000182141", "N0000185503"], "unii": ["83HN0GTJ6D"], "rxcui": ["241834", "835886", "835894", "835899", "835909", "835911"], "spl_set_id": ["94461af3-11f1-4670-95d4-2965b9538ae3"], "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 CARTON (0078-0246-15)  / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0246-61)", "package_ndc": "0078-0246-15", "marketing_start_date": "19950714"}], "brand_name": "Neoral", "product_id": "0078-0246_df11902a-3b90-428d-80f5-d587be982b4c", "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": "0078-0246", "generic_name": "cyclosporine", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Neoral", "active_ingredients": [{"name": "CYCLOSPORINE", "strength": "25 mg/1"}], "application_number": "NDA050715", "marketing_category": "NDA", "marketing_start_date": "19950714", "listing_expiration_date": "20261231"}