Cyclosporine

Product NDC: 0172-7313
11-digit product format: 001727313
Labeler code: 0172
Product ID: 0172-7313_94a2cdae-e60e-47c4-8bca-8baac9f21b33
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Cyclosporine
Dosage form: SOLUTION
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA065078
Marketing category: ANDA
Marketing start: 2005-03-29
Substance: CYCLOSPORINE
Active strength: 100 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

Additional Listing Data#

Ingredient, Strength table
Ingredient	Strength
CYCLOSPORINE	100 mg/mL

Field, Values table
Field	Values
Unii	83HN0GTJ6D
Rxcui	835886

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1be408a0-e15a-4092-b35e-4e294e65196f	Product name	3	20240216
b3fdee3e-0c46-442f-aad5-aa71941d5621	Product name	1	20231023
78fb0708-fce5-decd-6611-5a9fbe3e3dec	Product name	3	20230327
54840517-000d-4fcb-b976-a6ddd102faa0	Product name	1	20220120
a5ba3bd0-8411-4005-ac3b-a41d8ee0633a	Product name	1	20181029
b1c0d609-8b97-06ee-2cd0-5652a4b1d019	Product name	1	20140508

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0172-7313-20	Cyclosporine	1 in 1 PACKAGE	SOLUTION	1		18
0172-7313-20	Cyclosporine	50 mL in 1 BOTTLE	SOLUTION	50		18

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0172-7313-20	ML - Milliliter	0172-7313	b24be63b-050c-4dfa-8028-8d01ae712674	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CYCLOSPORINE	ACTIVE INGREDIENT	83HN0GTJ6D	CYCLOSPORINE SOLUTION [IVAX PHARMACEUTICALS, INC.]	12
CYCLOSPORINE	ACTIVE MOIETY	83HN0GTJ6D	CYCLOSPORINE SOLUTION [IVAX PHARMACEUTICALS, INC.]	12
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	CYCLOSPORINE SOLUTION [IVAX PHARMACEUTICALS, INC.]	12
POLYGLYCERYL-10 OLEATE	INACTIVE INGREDIENT	55C81W76DH	CYCLOSPORINE SOLUTION [IVAX PHARMACEUTICALS, INC.]	12
POLYGLYCERYL-3 OLEATE	INACTIVE INGREDIENT	XRQ165498B	CYCLOSPORINE SOLUTION [IVAX PHARMACEUTICALS, INC.]	12
POLYOXYL 40 HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	7YC686GQ8F	CYCLOSPORINE SOLUTION [IVAX PHARMACEUTICALS, INC.]	12

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0172-7313	CYCLOSPORINE SOLUTION [TEVA PHARMACEUTICALS USA, INC.]	18	Current NDC, Legacy NDC, 2 package rows	20250502_f3dc2a50-1084-4190-a6f3-37034a04db86.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
83HN0GTJ6D	CYCLOSPORINE	59865-13-3	CYCLOSPORINE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
835886	cycloSPORINE, modified 100 MG/mL Oral Solution	PSN	f3dc2a50-1084-4190-a6f3-37034a04db86	18
835886	cyclosporine, modified 100 MG/ML Oral Solution	SCD	f3dc2a50-1084-4190-a6f3-37034a04db86	18

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0172-7313-20	00172731320	1 BOTTLE in 1 PACKAGE (0172-7313-20) / 50 mL in 1 BOTTLE	1 bottle	2005-03-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
cycloSPORINE Oral Solution, USP MODIFIED	Teva Pharmaceuticals USA, Inc.	2024-07-01	HUMAN PRESCRIPTION DRUG LABEL	18