NDC Code(s) : 0093-9018-19, 0093-9018-65, 0093-9019-19, 0093-9019-65, 0093-9020-19, 0093-9020-65
Packager : Teva Pharmaceuticals USA, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-9018
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOSPORINE(UNII: 83HN0GTJ6D)
(CYCLOSPORINE - UNII:83HN0GTJ6D) 		CYCLOSPORINE25 mg
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
GELATIN(UNII: 2G86QN327L)
GLYCINE(UNII: TE7660XO1C)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOLINOLEATE(UNII: 4763AXI84L)
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
NONCRYSTALLIZING SORBITOL SOLUTION(UNII: 9E0S3UM200)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow Score no score
Shape CAPSULE (oval) Size 13 mm
Flavor Imprint Code 25;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-9018-6530 in 1 CARTON 06/08/2021
1NDC:0093-9018-191 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065110 06/08/2021
Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-9019
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOSPORINE(UNII: 83HN0GTJ6D)
(CYCLOSPORINE - UNII:83HN0GTJ6D) 		CYCLOSPORINE50 mg
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
GELATIN(UNII: 2G86QN327L)
GLYCINE(UNII: TE7660XO1C)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOLINOLEATE(UNII: 4763AXI84L)
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
NONCRYSTALLIZING SORBITOL SOLUTION(UNII: 9E0S3UM200)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color yellow (ochre-yellow) Score no score
Shape CAPSULE (oblong) Size 21 mm
Flavor Imprint Code 50;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-9019-6530 in 1 CARTON 06/08/2021
1NDC:0093-9019-191 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065110 06/08/2021
Cyclosporine Cyclosporine CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0093-9020
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOSPORINE(UNII: 83HN0GTJ6D)
(CYCLOSPORINE - UNII:83HN0GTJ6D) 		CYCLOSPORINE100 mg
Inactive Ingredients
Ingredient Name Strength
ALCOHOL(UNII: 3K9958V90M)
.ALPHA.-TOCOPHEROL, DL-(UNII: 7QWA1RIO01)
GELATIN(UNII: 2G86QN327L)
GLYCINE(UNII: TE7660XO1C)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOLINOLEATE(UNII: 4763AXI84L)
POLYOXYL 40 HYDROGENATED CASTOR OIL(UNII: 7YC686GQ8F)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
NONCRYSTALLIZING SORBITOL SOLUTION(UNII: 9E0S3UM200)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
BROWN IRON OXIDE(UNII: 1N032N7MFO)
Product Characteristics
Color brown Score no score
Shape CAPSULE (oblong) Size 25 mm
Flavor Imprint Code 100;mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0093-9020-6530 in 1 CARTON 06/08/2021
1NDC:0093-9020-191 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065110 06/08/2021

LABELER - Teva Pharmaceuticals USA, Inc.(001627975)

PRINCIPAL DISPLAY PANEL

NDC 0093-9018-65

New NDC

CycloSPORINE Capsules USP MODIFIED

(Soft Gelatin Capsules)

25 mg

WARNING: CycloSPORINE Capsules USP MODIFIED are NOT BIOEQUIVALENT to Sandimmune®

(CycloSPORINE Capsules USP). DO NOT use interchangeably without a physician’s supervision.

Rx only

30 SOFT GELATIN CAPSULES

1

PRINCIPAL DISPLAY PANEL

NDC 0093-9019-65

New NDC

CycloSPORINE Capsules USP MODIFIED

(Soft Gelatin Capsules)

50 mg

WARNING: CycloSPORINE Capsules USP MODIFIED are NOT BIOEQUIVALENT to Sandimmune®

(CycloSPORINE Capsules USP). DO NOT use interchangeably without a physician’s supervision.

Rx only

30 SOFT GELATIN CAPSULES

1

PRINCIPAL DISPLAY PANEL

NDC 0093-9020-65

New NDC

CycloSPORINE Capsules USP MODIFIED

(Soft Gelatin Capsules)

100 mg

WARNING: CycloSPORINE Capsules USP MODIFIED are NOT BIOEQUIVALENT to Sandimmune®

(CycloSPORINE Capsules USP). DO NOT use interchangeably without a physician’s supervision.

Rx only

30 SOFT GELATIN CAPSULES

1