Cyclosporine

Product NDC
0093-9019
11-digit product format
000939019
Labeler code
0093
Product ID
0093-9019_d5d977b4-fc80-4e46-ab55-280fd6d4ea12
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cyclosporine
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA065110
Marketing category
ANDA
Marketing start
2021-06-08
Substance
CYCLOSPORINE
Active strength
50 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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
83HN0GTJ6DCYCLOSPORINE59865-13-3CYCLOSPORINE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0093-9019-650009390196530 BLISTER PACK in 1 CARTON (0093-9019-65) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0093-9019-19) 30 blister pack2021-06-08NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
cycloSPORINE Capsules, USP MODIFIED (Soft Gelatin Capsules)Teva Pharmaceuticals USA, Inc.2024-04-01HUMAN PRESCRIPTION DRUG LABEL10