FDA.reportPublic FDA data

CycloSPORINE, Modfied

Product NDC
60505-4630
11-digit product format
605054630
Labeler code
60505
Product ID
60505-4630_5cee848b-4ce1-07e1-419d-8664662517d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclosporine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Apotex Corp.
Application
ANDA210721
Marketing category
ANDA
Marketing start
2019-11-05
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
CycloSPORINE, Modfied
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CYCLOSPORINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83HN0GTJ6D
Rxcui241834, 835894, 835925

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
60505-4630-3CycloSPORINE, Modfied30 in 1 CARTONCAPSULE, LIQUID FILLED309
60505-4630-3CycloSPORINE, Modfied10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-4630-3EA - Each60505-4630b0ee90e7-d140-4f1f-9790-506d734aa49d12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-4630CYCLOSPORINE, MODFIED (CYCLOSPORINE) CAPSULE, LIQUID FILLED [APOTEX CORP.]8Current NDC, Legacy NDC, 2 package rows20240925_5baaf78c-90f6-abcf-52c8-814490f3cf9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
241834cycloSPORINE, modified 100 MG Oral CapsulePSN5baaf78c-90f6-abcf-52c8-814490f3cf9f9
835894cycloSPORINE, modified 25 MG Oral CapsulePSN5baaf78c-90f6-abcf-52c8-814490f3cf9f9
835925cycloSPORINE, modified 50 MG Oral CapsulePSN5baaf78c-90f6-abcf-52c8-814490f3cf9f9
241834cyclosporine, modified 100 MG Oral CapsuleSCD5baaf78c-90f6-abcf-52c8-814490f3cf9f9
835894cyclosporine, modified 25 MG Oral CapsuleSCD5baaf78c-90f6-abcf-52c8-814490f3cf9f9
835925cyclosporine, modified 50 MG Oral CapsuleSCD5baaf78c-90f6-abcf-52c8-814490f3cf9f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-4630-36050546300330 BLISTER PACK in 1 CARTON (60505-4630-3) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK30 blister pack2019-11-050000-00-00NoNoCurrent