Cyclosporine

Product NDC
0574-0866
11-digit product format
005740866
Labeler code
0574
Product ID
0574-0866_6d2dc956-90ec-4fac-ad7f-8da7ca3f5299
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclosporine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Padagis US LLC
Application
ANDA065151
Marketing category
ANDA
Marketing start
2003-10-07
Marketing end
0000-00-00
Substance
CYCLOSPORINE
Active strength
50 mg/mL
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0574-0866-10ML - Milliliter0574-0866e13f3cdf-256e-4344-91c0-57ad7e19cb8612013-02-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0574-0866-100057408661010 AMPULE in 1 CARTON (0574-0866-10) > 5 mL in 1 AMPULE10 ampule2003-10-070000-00-00NoNoCurrent