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 2 of 7 · 130 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GUNA-CELLACETYLCARNITINE, L-AMPC-ALPHA-LIPOIC AC-A-TOCOPHEROL-ASCORBIC ACID-CALC CARB-CITRIC AC-COBALAMIN-COLCHICUM-CONIUM-CUPRIC SULF-HERRING SPERM DNA-FERROUS FUMARATE-FOLIC ACID-FUMARIC ACID-KALI ASPARTATE-MANG PHOS-MANG GLUCONATE-MANG PHOS II-PYRUVALDEHYDE-NAT OXALACETICUM-SODIUM PYRUVATE-NIACIN-PANTOTHENIC ACID-PH-PODOPHYLLUM PELTATUM-PYRIDOXINE HYDROCHLORIDE-RIBOFLAVIN-SACCHAROMYCES CEREVISIAE RNA-SELENOMETHIONINE-SUCCINIC ACID-SULFUR-THIAMINE HYDROCHLORIDE-ZINCGuna spa90db80ed-c037-4e8f-a7f6-304a65f9fe222026-06-11WarningsExact identifier
unii: 2968PHW8QP
GUNA-FLAMACONITUM NAPELLUS - APIS MELLIFERA - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - FERRIC PHOSPHATE - INTERLEUKIN-10 - MELATONIN - METENKEFALIN - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - SUS SCROFA CONJUNCTIVA - SUS SCROFA PINEAL GLAND - SUS SCROFA PITUITARY GLAND - TRANSFORMING GROWTH FACTOR BETA-1 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT -Guna spa7bda7eb0-8fd5-42d9-b336-39920bfc964d2026-06-10WarningsExact identifier
unii: 2968PHW8QP
Mycophenolate mofetilMYCOPHENOLATE MOFETILREMEDYREPACK INC.77a75d5b-a90d-4ee5-aa8a-6da97d1303572026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
Mycophenolate mofetilMYCOPHENOLATE MOFETILAscend Laboratories, LLC21ff53b0-b4ba-4473-91e4-76ef416810642026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
ACD ACITRIC ACID MONOHYDRATE, DEXTROSE MONOHYDRATE, AND TRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd8e255bc7-a120-460a-a32d-43931f8115de2026-05-21Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
mycophenolate mofetilMYCOPHENOLATE MOFETILBryant Ranch Prepack0f1704e2-a66a-4be5-8127-ebb5947c7b642026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
Mycophenolate MofetilMYCOPHENOLATE MOFETILPar Health USA, LLC35ba0428-e267-49a5-99a9-c58853f7989d2026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311881
unii: 9242ECW6R0
mycophenolate mofetilMYCOPHENOLATE MOFETILAccord Healthcare Inc.741e079a-646b-47ec-84ac-8e12574c2aaf2026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
Mycophenolate MofetilMYCOPHENOLATE MOFETILMeitheal Pharmaceuticals Inc.9650af9b-d36f-4a2f-9647-d0f7989334022026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311881
unii: 9242ECW6R0
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC58c24504-47de-487a-ab8d-18add155ea952026-04-07Adverse reactionsExact identifier
unii: 2968PHW8QP
Mycophenolate MofetilMYCOPHENOLATE MOFETILAscend Laboratories, LLC9f84ea84-2d8b-4d91-a33f-7dfb5df937dc2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: QTT17582CB
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
unii: 6OZP39ZG8H
TricitratesTRICITRATESChartwell Governmental & Specialty RX, LLC.c4ff0407-3930-4c48-afd4-d2cb3e1b18f42026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Potassium Citrate and Citric AcidPOTASSIUM CITRATE AND CITRIC ACIDChartwell Governmental & Specialty RX, LLC.fd57a176-7faf-4053-b348-6ba5f192f05a2026-02-25Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Mycophenolate mofetilMYCOPHENOLATE MOFETILMajor Pharmaceuticalsd176199c-dc3f-48c8-b7d2-c5d0a6a242fe2026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
Additive Formula 3DEXTROSE MONOHYDRATE, TRISODIUM CITRATE DIHYDRATE, SODIUM CHLORIDE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, CITRIC ACID MONOHYDRATE, AND ADENINETerumo BCT, Ltd9a5247a1-cc05-442d-b2d0-950f887f03c22026-01-30Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
SWISS BLEU Relief-Calm Antimicrobial Skin CreamLACTOBACILLUS FERMENT LYSATE, LEONTOPODIUM ALPINUM, CALENDULA OFFICINALIS FLOWER EXTRACT, EVENING PRIMROSE FLOWER EXTRACT, CITRIC ACIDNanjing Hongruixing Biological Technology Co., Ltd487d3c2c-ce28-f7a1-e063-6294a90a5ec62026-01-16WarningsExact identifier
unii: 2968PHW8QP
Mycophenolate MofetilMYCOPHENOLATE MOFETILCamber Pharmaceuticals, Inc.c3ded171-89da-4644-9ee8-dbcf6258036f2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0

Reported adverse events (FAERS/openFDA)#

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