NDC 71288-803-20 - 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
71288-803
Requested NDC
71288-803-20
Package NDCs from labels
71288-803-91, 71288-803-92, 71288-803-20, 71288-803-21
Manufacturer
Meitheal Pharmaceuticals Inc. | Kindos Pharmaceuticals Co., Ltd.
Effective date
2026-08-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mycophenolate MofetilMeitheal Pharmaceuticals Inc. | Kindos Pharmaceuticals Co., Ltd.2026-08-04HUMAN PRESCRIPTION DRUG LABEL
Mycophenolate MofetilMeitheal Pharmaceuticals Inc. | Kindos Pharmaceuticals Co., Ltd.2026-04-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-803-20Mycophenolate Mofetil20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,2015
71288-803-21Mycophenolate Mofetil4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,415
71288-803-91Mycophenolate Mofetil20 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,201
71288-803-92Mycophenolate Mofetil4 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-803MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]12Current NDC, Legacy NDC, 2 package rows20230908_9650af9b-d36f-4a2f-9647-d0f798933402.zip
71288-803MYCOPHENOLATE MOFETIL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, Legacy NDC, 2 package rows20240317_b41cca9f-0922-4171-8d1b-8e0d32ae1cc1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-803-20EA - Each71288-803ee249c0a-5862-42a3-99f9-78e85b7f73cc12021-04-08
71288-803-21EA - Each71288-8034083248a-a629-4bae-80e8-1f31c7cacc4312021-04-08
71288-803-91EA - Each71288-8030269d0ae-d3f5-4bd5-8990-be6c2545563812024-04-05
71288-803-92EA - Each71288-80322ff0dc9-db07-4d2c-b833-e30d6a91165812024-04-05

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 10 · 186 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
450771d2-0c98-4eef-bf1c-65702b4dde75b41cca9f-0922-4171-8d1b-8e0d32ae1cc12026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
spl set id: b41cca9f-0922-4171-8d1b-8e0d32ae1cc1
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
AdaptopathADENOSINUM CYCLOPHOSPHORICUM, ALPHA-LIPOICUM ACIDUM, ARGENTUM METALLICUM, AVENA SATIVA, CAPSICUM ANNUUM, CITRICUM ACIDUM, COENZYME A, CUPRUM METALLICUM, GINKGO BILOBA, GLANDULA SUPRARENALIS SUIS, GLYCYRRHIZA GLABRA, HYPOTHALAMUS (BOVINE), IODIUM, LEDUM PALUSTRE, MANGANUM ACETICUM, NADIDUM, NATRUM CARBONICUM, OLEUM MORRHUAE, PHOSPHORICUM ACIDUM, PICRICUM ACIDUM, RIBOFLAVINUM, SELENIUM METALLICUM SEPIA, SILICEA, THIAMINUM HYDROCHLORICUM, THYROIDINUM (BOVINE), VANADIUM METALLICUMEnergetix Corporation41234598-0cb5-41c2-bfbe-1c15ee9bf5022026-08-11WarningsExact identifier
unii: XF417D3PSL
Aller-Chord AALFALFA, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, BRYONIA (ALBA), CITRICUM ACIDUM, COUMARINUM, EUPHRASIA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, JUNIPERUS COMMUNIS, MUCOSA NASALIS SUIS, NATRUM SULPHURICUM, PHOSPHORUS, POTHOS FOETIDUS, PULSATILLA (VULGARIS), SOLIDAGO VIRGAUREA, SULPHUR, TANACETUM VULGARE, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSEEnergetix Corporation09e89c92-112d-4320-9df5-b9f938bb90952026-08-11WarningsExact identifier
unii: XF417D3PSL
Hepatic-ToneCARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CITRICUM ACIDUM, CYSTEINUM, HEPAR SUIS, LEPTANDRA VIRGINICA, MAGNESIA MURIATICA, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, QUASSIA (AMARA), TARAXACUM OFFICINALEEnergetix Corporationd5f61f13-7e9f-4e46-8ad8-0336f36288df2026-08-11WarningsExact identifier
unii: XF417D3PSL
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: XF417D3PSL
MetabopathADENOSINUM CYCLOPHOSPHORICUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, BERBERIS VULGARIS, CITRICUM ACIDUM, COENZYME A, DNA, FUMARICUM ACIDUM, GLYCYRRHIZA GLABRA, HEPAR SULPHURIS CALCAREUM, LAPPA MAJOR, MAGNESIA PHOSPHORICA, MANGANUM ACETICUM, NADIDUM, NATRUM MURIATICUM, NATRUM OXALACETICUM, NATRUM PYRUVICUM, NICOTINAMIDUM, PULSATILLA, PYRIDOXINUM HYDROCHLORICUM, RHAMNUS PURSHIANA, RIBOFLAVINUM, RNA, SILICEA, SUCCINICUM ACIDUM, SULPHUR, THIAMINUM HYDROCHLORICUM,Energetix Corporation58bfe670-d308-45a2-8046-7897b62214522026-08-11WarningsExact identifier
unii: XF417D3PSL
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
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
mycophenolate mofetilMYCOPHENOLATE MOFETILMajor Pharmaceuticals6abc5727-ee8e-43ad-ab39-0eef2feb257a2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: XF417D3PSL

Reported adverse events (FAERS/openFDA)#

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