FDA.reportPublic FDA data

X

Manufacturer
AX Pharmaceutical Corp
Effective date
2016-11-23
Label type
BULK INGREDIENT
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:21:28

Label at a glance#

ProductX
Active ingredientMycophenolate Mofetil
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62157-36962157-369-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
Mycophenolate Mofetil9242ECW6R0ACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mycophenolate mofetilMYCOPHENOLATE MOFETILREMEDYREPACK INC.84c6f6bb-8924-4da5-9629-126197195f832026-09-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetilMYCOPHENOLATE MOFETILStrides Pharma Inc.9d8c09fc-1df2-4f39-8e1a-c4b296d1a2602026-09-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILTeva Pharmaceuticals USA, Inc.b414303f-e6f3-4e22-a537-96be352b59a42026-08-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
mycophenolate mofetilMYCOPHENOLATE MOFETILAvPAKfbbe6521-0e21-5372-e053-6394a90ae5e42026-08-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILAmneal Pharmaceuticals LLC27fd9381-8d82-4187-897f-98f41f94e90f2026-08-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILA-S Medication Solutionsb4170ad9-67f0-42ea-b694-6b80824a607a2026-08-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILQUAGEN PHARMACEUTICALS LLC838449b3-4397-4e35-b9b9-683f5a48bff22026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
CellCeptMYCOPHENOLATE MOFETILGenentech, Inc.37241e87-4af4-4dc3-a1aa-ea6f20d8dc402026-08-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
mycophenolate mofetilMYCOPHENOLATE MOFETILMajor Pharmaceuticals6abc5727-ee8e-43ad-ab39-0eef2feb257a2026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILREMEDYREPACK INC.d203775c-bf36-460c-bacf-3ab2348a514f2026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetilMYCOPHENOLATE MOFETILREMEDYREPACK INC.77a75d5b-a90d-4ee5-aa8a-6da97d1303572026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetilMYCOPHENOLATE MOFETILAscend Laboratories, LLC21ff53b0-b4ba-4473-91e4-76ef416810642026-05-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
mycophenolate mofetilMYCOPHENOLATE MOFETILBryant Ranch Prepack0f1704e2-a66a-4be5-8127-ebb5947c7b642026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILPar Health USA, LLC35ba0428-e267-49a5-99a9-c58853f7989d2026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
mycophenolate mofetilMYCOPHENOLATE MOFETILAccord Healthcare Inc.741e079a-646b-47ec-84ac-8e12574c2aaf2026-04-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILMeitheal Pharmaceuticals Inc.9650af9b-d36f-4a2f-9647-d0f7989334022026-04-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILAscend Laboratories, LLC9f84ea84-2d8b-4d91-a33f-7dfb5df937dc2026-03-26Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate mofetilMYCOPHENOLATE MOFETILMajor Pharmaceuticalsd176199c-dc3f-48c8-b7d2-c5d0a6a242fe2026-02-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
Mycophenolate MofetilMYCOPHENOLATE MOFETILCamber Pharmaceuticals, Inc.c3ded171-89da-4644-9ee8-dbcf6258036f2026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL
MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILNorthStar Rx LLC127eabe2-8386-452a-ad6b-d879e1f2c0992026-01-08Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MYCOPHENOLATE MOFETIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.