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 · 188 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATECardinal Health 107, LLCb3d5225c-0ee4-481e-b9ec-bc5e1321096d2026-06-12Adverse reactionsExact identifier
unii: XF417D3PSL
Mycophenolate mofetilMYCOPHENOLATE MOFETILREMEDYREPACK INC.77a75d5b-a90d-4ee5-aa8a-6da97d1303572026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-06-03WarningsExact identifier
unii: 6OZP39ZG8H
Mycophenolate mofetilMYCOPHENOLATE MOFETILAscend Laboratories, LLC21ff53b0-b4ba-4473-91e4-76ef416810642026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
unii: XF417D3PSL
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
CLENPIQSODIUM PICOSULFATE, MAGNESIUM OXIDE, AND ANHYDROUS CITRIC ACIDFerring Pharmaceuticals Inc.e95fff66-4ec0-4001-a727-33e66a5ec7d52026-04-15Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Mycophenolate MofetilMYCOPHENOLATE MOFETILMeitheal Pharmaceuticals Inc.9650af9b-d36f-4a2f-9647-d0f7989334022026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA212130
ndc (package): 71288-803-21
ndc (package): 71288-803-20
ndc (product): 71288-803
ndc11 (package): 71288080320
rxcui: 311881
spl id: 8c49656c-3408-41e6-be90-e003e057d2fc
spl set id: 9650af9b-d36f-4a2f-9647-d0f798933402
unii: 9242ECW6R0
MYHIBBINMYCOPHENOLATE MOFETILAzurity Pharmaceuticals, Inc.d9af72d6-7b3e-4c08-94b9-1d8b499cb7f92026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9242ECW6R0