FDA.reportPublic FDA data

NDC 67457-386-00 - Mycophenolate Mofetil

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67457-386
Requested NDC
67457-386-00
Package NDCs from labels
67457-386-00, 67457-386-81
Manufacturer
Mylan Institutional LLC | Mylan Pharmaceuticals Inc. | Mylan Laboratories Limited
Effective date
2025-07-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mycophenolate Mofetil - Mylan Institutional LLC | Mylan Pharmaceuticals Inc. | Mylan Laboratories LimitedMylan Institutional LLC | Mylan Pharmaceuticals Inc. | Mylan Laboratories Limited2025-07-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67457-386-00Mycophenolate Mofetil20 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,205
67457-386-81Mycophenolate Mofetil4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67457-386MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MYLAN INSTITUTIONAL LLC]4Current NDC, Legacy NDC, 2 package rows20230105_da02b428-42a4-4007-b0b7-695f2db010f2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67457-386-00EA - Each67457-3863afe1252-bb2e-4891-8c8a-163debf63f4012021-02-05
67457-386-81EA - Each67457-386070a222c-e38b-4cb3-ac5e-28f9ec309db312021-02-05

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 7 · 130 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 reactionsExact identifier
unii: 9242ECW6R0
Mycophenolate mofetilMYCOPHENOLATE MOFETILStrides Pharma Inc.9d8c09fc-1df2-4f39-8e1a-c4b296d1a2602026-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
Mycophenolate MofetilMYCOPHENOLATE MOFETILTeva Pharmaceuticals USA, Inc.b414303f-e6f3-4e22-a537-96be352b59a42026-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
mycophenolate mofetilMYCOPHENOLATE MOFETILAvPAKfbbe6521-0e21-5372-e053-6394a90ae5e42026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
Mycophenolate MofetilMYCOPHENOLATE MOFETILAmneal Pharmaceuticals LLC27fd9381-8d82-4187-897f-98f41f94e90f2026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
Mycophenolate MofetilMYCOPHENOLATE MOFETILA-S Medication Solutionsb4170ad9-67f0-42ea-b694-6b80824a607a2026-08-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
Mycophenolate MofetilMYCOPHENOLATE MOFETILQUAGEN PHARMACEUTICALS LLC838449b3-4397-4e35-b9b9-683f5a48bff22026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
CellCeptMYCOPHENOLATE MOFETILGenentech, Inc.37241e87-4af4-4dc3-a1aa-ea6f20d8dc402026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311881
unii: 9242ECW6R0
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
mycophenolate mofetilMYCOPHENOLATE MOFETILMajor Pharmaceuticals6abc5727-ee8e-43ad-ab39-0eef2feb257a2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 2968PHW8QP
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd.395aec48-198a-4aed-8e38-7accfb3232f92026-06-15Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDTotal Operations Management LLC DBA:Bestmade Natural Products Micro5423bde6-3e31-38b0-e063-6294a90afb2d2026-06-13WarningsExact identifier
unii: QTT17582CB
BM BM182 DROPSHEPAR SULF, GRAPHITES, MERC SOL, MURIATIC ACIDBM Private Limited540d11e3-e4a1-0ca2-e063-6394a90a3c262026-06-12WarningsExact identifier
unii: QTT17582CB
MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILREMEDYREPACK INC.d203775c-bf36-460c-bacf-3ab2348a514f2026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0

Reported adverse events (FAERS/openFDA)#

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