FDA.reportPublic FDA data

NDC 68254-5000-01 - 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
68254-5000
Requested NDC
68254-5000-01
Package NDCs from labels
68254-5000-2, 68254-5000-1, 68254-5000-01
Manufacturer
CONCORD BIOTECH LIMITED
Effective date
2025-07-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
MYCOPHENOLATE MOFETIL - CONCORD BIOTECH LIMITEDCONCORD BIOTECH LIMITED2025-07-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68254-5000-1MYCOPHENOLATE MOFETIL100 in 1 BOTTLECAPSULE10018
68254-5000-2MYCOPHENOLATE MOFETIL500 in 1 BOTTLECAPSULE50018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68254-5000MYCOPHENOLATE MOFETIL CAPSULE MYCOPHENOLATE MOFETIL TABLET [CONCORD BIOTECH LIMITED]17Current NDC, Legacy NDC, 2 package rows20240514_64ac00ee-298c-49cf-a91c-78019a0d014d.zip

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 31 of 294 · 5,865 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILREMEDYREPACK INC.d203775c-bf36-460c-bacf-3ab2348a514f2026-06-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210181
rxcui: 199058
unii: 9242ECW6R0
Smart Care Hand Sanitizer Fall Scents-AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.541a09b6-2928-9fbf-e063-6394a90a3c4d2026-06-12WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Holiday-Spiced CranberryALCOHOLShenzhen Lantern Scicence Co.,Ltd.541a41cf-5c63-c6fc-e063-6294a90abfcc2026-06-12WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Holiday-MistletoeALCOHOLShenzhen Lantern Scicence Co.,Ltd.541a8aa9-1d4b-28ec-e063-6294a90aa34e2026-06-12WarningsExact identifier
unii: 3K9958V90M
Visine Red Eye Total Comfort Multi-SymptomTETRAHYDROZOLINE HYDROCHLORIDE, POLYETHYLENE GLYCOL 400, AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC5747edef-7a87-41d7-9594-6c78508b9ba22026-06-11WarningsExact identifier
unii: B697894SGQ
tazza 63% alcohol foam sanitizerETHANOLTazza Brands East, Inc.53f19eae-7e6f-bdee-e063-6294a90a82c72026-06-11WarningsExact identifier
unii: 3K9958V90M
Hand SanitizerALCOHOLGuangdong Yanze Biotechnology Co., Ltd.5211ec31-90bc-e0fc-e063-6294a90a76ed2026-06-11WarningsExact identifier
unii: 3K9958V90M
Smart Care Squishmallows Hand SanitizerALCOHOLShenzhen Lantern Scicence Co.,Ltd.53f5d658-dd1a-bb8e-e063-6294a90adbb12026-06-11WarningsExact identifier
unii: 3K9958V90M
Smart Care Hand Sanitizer Fall Scents-Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.53f6c000-849b-0045-e063-6294a90aa2f12026-06-11WarningsExact identifier
unii: 3K9958V90M
BM BM70 DROPSANTIM CURD, FERR MET, PHOSPHORUS, SULPHUR, WIESBADEN, THUJA, VERATRUM ALBBM Private Limited53fa21d9-1f80-2e69-e063-6394a90ab9f32026-06-11WarningsExact identifier
unii: 059QF0KO0R
it cosmetics Your Skin But Better CC Plus Natural Matte Color Correcting Pore Refining Full Coverage Skin Balancing Serum Broad Spectrum SPF 40 SunscreenENSULIZOLE, OCTISALATE AND TITANIUM DIOXIDEIT COSMETICS, LLCf2990320-b61d-40b8-ba79-18d6b37e7f522026-06-11WarningsExact identifier
unii: 15FIX9V2JP
EVR Alcohol Prep PadsLSOPROPYL ALCOHOLJINHUA JINGDI MEDICAL SUPPLIES CO.,LTD5406ba2f-6729-b9e7-e063-6394a90ac5532026-06-11WarningsExact identifier
unii: ND2M416302
MISTIFY FROSTY CANDY HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd53e4f854-750b-7322-e063-6294a90a11102026-06-10WarningsExact identifier
unii: 3K9958V90M
WhiskCare 371ALCOHOLWhisk Products, Inc.bc505f53-2cc9-4cd1-8b34-8d0be4e32aea2026-06-10WarningsExact identifier
unii: 3K9958V90M
Isopropyl alcoholISOPROPYL ALCOHOLCVS PHARMACY, INCb30468f6-7a1b-4165-916f-36df21eb10e52026-06-09WarningsExact identifier
unii: ND2M416302
RE-NUTRIV AGE REVERSAL VITAL RADIANCE SERUM FOUNDATION SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d76b02-442e-7a5d-e063-6394a90ae1b32026-06-09WarningsExact identifier
unii: 15FIX9V2JP
B-Pure Moisturizing Hand Sanitizer Alpine Chalet ScentedALCOHOLFourstar Group USA, Inc.03e83cf4-ac40-4208-943a-380a87bbf2a12026-06-09WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer Polar Berry ScentedALCOHOLFourstar Group USA, Inc.d1fa6ca0-ba85-4bb7-a7ae-b9ac0c39ea352026-06-09WarningsExact identifier
unii: 3K9958V90M
FUTURIST HYDRATING COLLAGEN-PEPTIDE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC53d9d689-4a86-5b9c-e063-6394a90aef182026-06-09WarningsExact identifier
unii: 15FIX9V2JP
Smart Care Assorted Hand Sanitizer Pumpkin SpiceALCOHOLShenzhen Lantern Scicence Co.,Ltd.53dd3d76-81c9-ed6b-e063-6394a90aaea32026-06-09WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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