NDC Code(s) : 0591-2222-15, 0591-2223-15, 0591-2224-55
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CycloSPORINECycloSPORINE CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2222
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
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE(UNII: TM2TZD4G4A)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES(UNII: 00BT03FSO2)
POLYOXYL 35 CASTOR OIL(UNII: 6D4M1DAL6O)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SHELLAC(UNII: 46N107B71O)
SORBITOL(UNII: 506T60A25R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (Off-White) Score no score
Shape OVAL Size 9 mm
Flavor Imprint Code PA09
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-2222-151 in 1 BOX 12/01/2008
130 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 ANDA065044 12/01/2008
CycloSPORINECycloSPORINE CAPSULE, LIQUID FILLED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2223
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
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
GLYCERYL MONOCAPRYLATE(UNII: TM2TZD4G4A)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES(UNII: 00BT03FSO2)
POLYOXYL 35 CASTOR OIL(UNII: 6D4M1DAL6O)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SHELLAC(UNII: 46N107B71O)
SORBITOL(UNII: 506T60A25R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color WHITE (Off-White) Score no score
Shape OVAL (Oblong) Size 22 mm
Flavor Imprint Code PA20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-2223-151 in 1 BOX 12/01/2008
130 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 ANDA065044 12/01/2008
CycloSPORINECycloSPORINE SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0591-2224
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYCLOSPORINE(UNII: 83HN0GTJ6D)
(CYCLOSPORINE - UNII:83HN0GTJ6D) 		CYCLOSPORINE100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MEDIUM-CHAIN TRIGLYCERIDES(UNII: C9H2L21V7U)
GLYCERYL MONOCAPRYLATE(UNII: TM2TZD4G4A)
POLYOXYL 35 CASTOR OIL(UNII: 6D4M1DAL6O)
ALPHA-TOCOPHEROL(UNII: H4N855PNZ1)
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES(UNII: 00BT03FSO2)
Product Characteristics
Color YELLOW (Light Yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0591-2224-551 in 1 BOX 12/01/2008
150 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065054 12/01/2008

PRINCIPAL DISPLAY PANEL

NDC 0591-2222-15
CycloSPORINE Capsules, USP
[MODIFIED]
25 mg
WARNING: CycloSPORINE capsules, USP [MODIFIED] is NOT BIOEQUIVALENT to Sandimmune®* (CycloSPORINE capsules, USP [NON-MODIFIED]). Do NOT use interchangeably without a physician’s supervision.
This unit-dose package is not child-resistant.
Rx only
*Sandimmune® is a registered trademark of
Novartis Pharmaceuticals Corporation.
30 Soft Gelatin Capsules
Watson ®

25mg caps label

PRINCIPAL DISPLAY PANEL

NDC 0591-2223-15
CycloSPORINE Capsules, USP
[MODIFIED]
100 mg
WARNING: CycloSPORINE capsules, USP [MODIFIED] is NOT BIOEQUIVALENT to Sandimmune®* (CycloSPORINE capsules, USP [NON-MODIFIED]). Do NOT use interchangeably without a physician’s supervision.
This unit-dose package is not child-resistant.
Rx only
*Sandimmune® is a registered trademark of
Novartis Pharmaceuticals Corporation.
30 Soft Gelatin Capsules
Watson ®

100mg caps label

PRINCIPAL DISPLAY PANEL

NDC 0591-2224-55
CycloSPORINE Oral Solution, USP
[MODIFIED]
100 mg/mL
WARNING: CycloSPORINE oral solution, USP [MODIFIED] is NOT BIOEQUIVALENT to Sandimmune®* (CycloSPORINE oral solution, USP [NON-MODIFIED]). Do NOT use interchangeably without a physician’s supervision.
EACH mL CONTAINS: CycloSPORINE, USP………………………………………………100 mg
Inactive Ingredients: Caprylic/capric triglyceride, dl-alpha-tocopherol, glyceryl caprylate, PEG-8 caprylic/capric glycerides, PEG-35 castor oil.

Rx only
50 mL Size 
Watson ®

100mg mL solution label