Cyclosporine

Product NDC
64380-127
11-digit product format
643800127
Labeler code
64380
Product ID
64380-127_f42ec7ac-b9f1-4097-ab63-9edda82f5fff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclosporine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA216046
Marketing category
ANDA
Marketing start
2022-08-16
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-127CYCLOSPORINE CAPSULE, LIQUID FILLED [STRIDES PHARMA SCIENCE LIMITED]5Legacy NDC20240224_c36132b2-3ec7-4c43-a25e-75cbdbe3d88d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-127-02643800127023 BLISTER PACK in 1 CARTON (64380-127-02) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (64380-127-01) 3 blister pack2022-08-160000-00-00NoNoCurrent