NDC Code(s) : 23155-836-01, 23155-836-05
Packager : Avet Pharmaceuticals Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Mycophenolate mofetil Mycophenolate mofetil TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-836
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MYCOPHENOLATE MOFETIL(UNII: 9242ECW6R0)
(MYCOPHENOLIC ACID - UNII:HU9DX48N0T) 		MYCOPHENOLATE MOFETIL500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POVIDONE K30(UNII: U725QWY32X)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code SAL725
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:23155-836-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/10/2022
2NDC:23155-836-05500 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/10/2022
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090456 10/15/2022

LABELER - Avet Pharmaceuticals Inc(780779901)

PRINCIPAL DISPLAY PANEL

Mycophenolate Mofetil Tablets, USP

500 mg

Rx Only

100 Tablets

NDC 21355-836-01

100s count

Mycophenolate Mofetil Tablets, USP

500 mg

Rx Only

500 Tablets

NDC 21355-836-05

100s count