Viewing data from:

CYCLOSPORINE

ANDA

CYCLOSPORINE | A065040 | APOTEX INC

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: SANDIMMUNE(TE code: AB2)

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 4 NDCs

Highest NADAC/Unit

$7.29

per ea

Lowest NADAC/Unit

$2.58

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
68084092125CYCLOSPORINE 100 MG CAPSULE	$7.29	EA	Generic	—	2026-08-19
60505013400CYCLOSPORINE 100 MG CAPSULE	$7.29	EA	Generic	—	2026-08-19
68084087925CYCLOSPORINE 25 MG CAPSULE	$2.58	EA	Generic	—	2026-08-19
60505013300CYCLOSPORINE 25 MG CAPSULE	$2.58	EA	Generic	—	2026-08-19

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$82.99

Highest Price

$333.90

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
60505-0133-00CYCLOSPORINE NON-MODIFIED 25MG CAP	$82.99	FSS	AvKare, LLC	06/14/2028
60505-0134-00CYCLOSPORINE NON-MODIFIED 100MG CAP	$333.90	FSS	AvKare, LLC	06/14/2028

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain15 active DMFs7 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

CKD BIO CORPCYCLOSPORINE, NON-STERILE BULK, USP

DMF 122141996

TAPI NL BVCYCLOSPORINE

DMF 129321998

CURIA ITALY SRLCYCLOSPORINE

DMF 129491998

FUJIAN KERUI PHARMACEUTICAL CO LTDCYCLOSPORINE

DMF 137891998

TAPI NL BVCYCLOSPORINE

DMF 137991998

ABBVIE INCCYCLOSPORINE USP

DMF 138001998

APOTEX INCCYCLOSPORINE USP (BULK)

DMF 139291999

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDCYCLOSPORINE (NON-STERILE BULK FORM)

DMF 189322005

CONCORD BIOTECH LTDCYCLOSPORINE USP

DMF 239622010

ZHEJIANG RUIBANG LABORATORIESCYCLOSPORINE

DMF 285122014

TAPI NL BVCYCLOSPORINE ID: 741710

DMF 295572015

NORTH CHINA PHARMACEUTICAL HUASHENG CO LTDCYCLOSPORINE USP, NON-STERILE BULK DRUG SUBSTANCE

DMF 339462019

TAPI NL BVCYCLOSPORINE ID: 741310

DMF 346422020

CURIA ITALY SRLCYCLOSPORINE 350507

DMF 363852021

FISHFA BIOGENICS (A DIV OF FISHFA RUBBERS LTD)CYCLOSPORINE USP

DMF 429662025

NORTH CHINA PHARMACEUTICAL CORPInactiveCYCLOSPORINE, USP (BULK, NON-STERILE)

DMF 102811993

SANDOZ PHARMA LTDInactiveCYCLOSPORINE MANFACTURED IN BASLE, SWITZERLAND.

DMF 116181995

GALENA ASInactiveCYCLOSPORINE

DMF 119711996

ZHEJIANG RUIBANG LABORATORIES INCInactiveCYCLOSPORINE

DMF 138581998

NORTH CHINA PHARMACEUTICAL CORPInactiveCYCLOSPORINE, USP (NON STERILE BULK)

DMF 143151998

WATSON LABORATORIES INCInactiveCYCLOSPORINE

DMF 153282001

ZHEJIANG RUIBANG LABORATORIESInactiveCYCLOSPORINE CRUDE

DMF 314652018

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Apr 9, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 25MG

AB2

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: May 9, 2002

No patent or exclusivity listings for this strength.

#002 — 100MG

AB2

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 9, 2002