NDC Code(s) : 24979-161-44, 24979-160-44
Packager : TWi Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

mycophenolic acidmycophenolic acid TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-161
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MYCOPHENOLATE SODIUM(UNII: WX877SQI1G)
(MYCOPHENOLIC ACID - UNII:HU9DX48N0T) 		MYCOPHENOLIC ACID360 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CROSPOVIDONE(UNII: 2S7830E561)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(UNII: 87Y6436BKR)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL 4000(UNII: 4R4HFI6D95)
POVIDONE K30(UNII: U725QWY32X)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color ORANGE Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code T161
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24979-161-44120 in 1 BOTTLE Type 0: Not a Combination Product11/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214289 11/08/2021
mycophenolic acidmycophenolic acid TABLET, DELAYED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-160
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MYCOPHENOLATE SODIUM(UNII: WX877SQI1G)
(MYCOPHENOLIC ACID - UNII:HU9DX48N0T) 		MYCOPHENOLIC ACID180 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE(UNII: 3SY5LH9PMK)
CROSPOVIDONE(UNII: 2S7830E561)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (15 MPA.S)(UNII: 36SFW2JZ0W)
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)(UNII: 87Y6436BKR)
MAGNESIUM STEARATE(UNII: 70097M6I30)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
STARCH, CORN(UNII: O8232NY3SJ)
POVIDONE K30(UNII: U725QWY32X)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color white Score no score
Shape ROUND Size 10 mm
Flavor Imprint Code T160
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:24979-160-44120 in 1 BOTTLE Type 0: Not a Combination Product11/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214289 11/08/2021

LABELER - TWi Pharmaceuticals, Inc.(658402052)

REGISTRANT - TWi Pharmaceuticals, Inc.(658402052)

Establishment
Name Address ID/FEI Business Operations
TWi Pharmaceuticals, Inc. Zhongli Plant 658863394 analysis(24979-160, 24979-161), manufacture(24979-160, 24979-161), pack(24979-160, 24979-161)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Package Label – 180 mg

Rx Only             NDC 24979-160-44

Mycophenolic acid delayed-release tablets

Dispense the accompanying Medication Guide to each patient.

120 Tablets

PRINCIPAL DISPLAY PANEL Package Label – 180 mg Rx Only NDC 0078-0385-66

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

Package Label – 360 mg

Rx Only             NDC 24979-161-44

Mycophenolic acid delayed-release tablets

Dispense the accompanying Medication Guide to each patient.

120 Tablets

PRINCIPAL DISPLAY PANEL Package Label – 360 mg Rx Only NDC 0078-0386-66