Cyclosporine

Product NDC
0480-4076
11-digit product format
004804076
Labeler code
0480
Product ID
0480-4076_0dc3c832-fe01-4913-ba52-47cca4c890b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclosporine
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Teva Pharmaceuticals, Inc.
Application
ANDA203880
Marketing category
ANDA
Marketing start
2025-10-28
Substance
CYCLOSPORINE
Active strength
.5 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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
83HN0GTJ6DCYCLOSPORINE59865-13-3CYCLOSPORINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0480-4076-30004804076306 POUCH in 1 CARTON (0480-4076-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE6 pouch2025-10-28NoNoHistorical
0480-4076-600048040766012 POUCH in 1 CARTON (0480-4076-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE12 pouch2025-10-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Cyclosporine - Teva Pharmaceuticals, Inc.Teva Pharmaceuticals, Inc.2024-03-01HUMAN PRESCRIPTION DRUG LABEL6