Cyclosporine

Product NDC
51862-460
11-digit product format
518620460
Labeler code
51862
Product ID
51862-460_2401a70a-8308-4b1b-b1c8-05b91ec230a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclosporine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Mayne Pharma Inc.
Application
ANDA065044
Marketing category
ANDA
Marketing start
2016-07-18
Marketing end
0000-00-00
Substance
CYCLOSPORINE
Active strength
100 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
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
51862-460-01EA - Each51862-4601ddf71c7-e5c7-4580-a813-bc2825e872e412016-09-02
51862-460-47EA - Each51862-4600d4f82f2-36b1-4eec-9b57-6ae53053ccbe12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-460CYCLOSPORINE CAPSULE, LIQUID FILLED [MAYNE PHARMA INC.]10Legacy NDC20210918_e7165673-8ab1-4fc8-85e5-a67135af7a7f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-460-475186204604730 BLISTER PACK in 1 BOX (51862-460-47) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (51862-460-01) 30 blister pack2016-07-180000-00-00NoNoCurrent