FDA.reportPublic FDA data

Neoral

Product NDC
0078-0246
11-digit product format
000780246
Labeler code
0078
Product ID
0078-0246_df11902a-3b90-428d-80f5-d587be982b4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cyclosporine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA050715
Marketing category
NDA
Marketing start
1995-07-14
Substance
CYCLOSPORINE
Active strength
25 mg/1
Pharmacologic classes
Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Neoral
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOSPORINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83HN0GTJ6D
Rxcui241834, 835886, 835894, 835899, 835909, 835911

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1be408a0-e15a-4092-b35e-4e294e65196fProduct name320240216
b3fdee3e-0c46-442f-aad5-aa71941d5621Product name120231023
78fb0708-fce5-decd-6611-5a9fbe3e3decProduct name320230327
54840517-000d-4fcb-b976-a6ddd102faa0Product name120220120
a5ba3bd0-8411-4005-ac3b-a41d8ee0633aProduct name120181029
b1c0d609-8b97-06ee-2cd0-5652a4b1d019Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0246-15Neoral30 in 1 CARTONCAPSULE, LIQUID FILLED3028
0078-0246-61Neoral1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED128

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0246-15EA - Each0078-024681a761e3-867e-4db2-a3cf-2801fd35978c12012-07-24
0078-0246-61EA - Each0078-0246f39aa372-6e43-4849-8735-6541007dfadb12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CYCLOSPORINEACTIVE INGREDIENT83HN0GTJ6DNEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]15
CYCLOSPORINEACTIVE MOIETY83HN0GTJ6DNEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]15
COCHINEALINACTIVE INGREDIENTTZ8Z31B35MNEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]15
CORN OILINACTIVE INGREDIENT8470G57WFMNEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]15
GELATININACTIVE INGREDIENT2G86QN327LNEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]15
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]15
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8FNEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]15
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]15
TOCOPHEROLINACTIVE INGREDIENTR0ZB2556P8NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0246NEORAL (CYCLOSPORINE) CAPSULE, LIQUID FILLED NEORAL (CYCLOSPORINE) SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION]26Current NDC, Legacy NDC, 2 package rows20240719_94461af3-11f1-4670-95d4-2965b9538ae3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
241834cycloSPORINE, modified 100 MG Oral CapsulePSN94461af3-11f1-4670-95d4-2965b9538ae328
835886cycloSPORINE, modified 100 MG/mL Oral SolutionPSN94461af3-11f1-4670-95d4-2965b9538ae328
835894cycloSPORINE, modified 25 MG Oral CapsulePSN94461af3-11f1-4670-95d4-2965b9538ae328
835899NEORAL 100 MG in 1 mL Oral SolutionPSN94461af3-11f1-4670-95d4-2965b9538ae328
835911Neoral 100 MG Oral CapsulePSN94461af3-11f1-4670-95d4-2965b9538ae328
835909Neoral 25 MG Oral CapsulePSN94461af3-11f1-4670-95d4-2965b9538ae328
835911cyclosporine, modified 100 MG Oral Capsule [Neoral]SBD94461af3-11f1-4670-95d4-2965b9538ae328
835899cyclosporine, modified 100 MG/ML Oral Solution [Neoral]SBD94461af3-11f1-4670-95d4-2965b9538ae328
835909cyclosporine, modified 25 MG Oral Capsule [Neoral]SBD94461af3-11f1-4670-95d4-2965b9538ae328
241834cyclosporine, modified 100 MG Oral CapsuleSCD94461af3-11f1-4670-95d4-2965b9538ae328
835886cyclosporine, modified 100 MG/ML Oral SolutionSCD94461af3-11f1-4670-95d4-2965b9538ae328
835894cyclosporine, modified 25 MG Oral CapsuleSCD94461af3-11f1-4670-95d4-2965b9538ae328
835911Neoral 100 MG Oral CapsuleSY94461af3-11f1-4670-95d4-2965b9538ae328
835899Neoral 100 MG per 1 ML Oral SolutionSY94461af3-11f1-4670-95d4-2965b9538ae328
835909Neoral 25 MG Oral CapsuleSY94461af3-11f1-4670-95d4-2965b9538ae328

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0246-150007802461530 BLISTER PACK in 1 CARTON (0078-0246-15) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0078-0246-61) 30 blister pack1995-07-140000-00-00NoNoCurrent
0078-0246-61000780246611 in 1 BLISTER PACKHistorical