Mycophenolate Mofetil (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mycophenolate Mofetil Capsules, USP

250 mg

Rx Only

100 Capsules

NDC 23155-830-01

Capsules -- 100s count
(click image for full-size original)

Mycophenolate Mofetil Tablets, USP

500 mg

Rx Only

100 Tablets

NDC 23155-836-05

Tablets -- 500s count
(click image for full-size original)
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 (MYCOPHENOLIC ACID) MYCOPHENOLATE MOFETIL 500 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 1
FD&C RED NO. 40
HYPROMELLOSES
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POVIDONE K30
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
FERRIC OXIDE RED
Product Characteristics
Color BROWN Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code SAL725
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:23155-836-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
2 NDC:23155-836-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090456 10/15/2022
MYCOPHENOLATE MOFETIL mycophenolate mofetil capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23155-830
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MYCOPHENOLATE MOFETIL (MYCOPHENOLIC ACID) MYCOPHENOLATE MOFETIL 250 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
FD&C RED NO. 3
FERRIC OXIDE YELLOW
GELATIN
MAGNESIUM STEARATE
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
POVIDONE K30
CELLULOSE, MICROCRYSTALLINE
Product Characteristics
Color WHITE (IVORY) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code SAL726
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:23155-830-01 100 CAPSULE in 1 BOTTLE, PLASTIC None
2 NDC:23155-830-05 500 CAPSULE in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090055 06/30/2022
Labeler — Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (780779901)

Revised: 11/2023 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.