FDA.reportPublic FDA data

NDC 0006-4305-01 - Renflexis

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
0006-4305
Requested NDC
0006-4305-01
Package NDCs from labels
0006-4305-01, 0006-4305-02
Manufacturer
Merck Sharp & Dohme LLC | Samsung Bioepis Co., Ltd.
Effective date
2023-01-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Renflexis - Merck Sharp & Dohme LLC | Samsung Bioepis Co., Ltd.Merck Sharp & Dohme LLC | Samsung Bioepis Co., Ltd.2023-01-26HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0006-4305-022025-01-30C16284748780-1f386c649-e6fb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RENFLEXIS safely and effectively. See full prescribing information for RENFLEXIS. RENFLEXIS (infliximab-abda) for injection, for intravenous use Initial U.S. Approval: 2017 RENFLEXIS (infliximab-abda) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differe
0006-4305-022023-02-03C16284748780-1f386c649-e6fb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RENFLEXIS safely and effectively. See full prescribing information for RENFLEXIS. RENFLEXIS (infliximab-abda) for injection, for intravenous use Initial U.S. Approval: 2017 RENFLEXIS (infliximab-abda) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differe
0006-4305-022023-01-30C16284748780-1f386c649-e6fb-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use RENFLEXIS safely and effectively. See full prescribing information for RENFLEXIS. RENFLEXIS (infliximab-abda) for injection, for intravenous use Initial U.S. Approval: 2017 RENFLEXIS (infliximab-abda) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0006-4305-01Renflexis1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,114
0006-4305-02Renflexis1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0006-4305RENFLEXIS (INFLIXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]14Legacy NDC, 2 package rows20230204_3827e1be-f328-45f7-b113-311b57039f8c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0006-4305-01EA - Each0006-43051610e94a-cf30-4667-b4ea-b6bd43075da312017-08-11
0006-4305-02EA - Each0006-4305d0969126-a49f-4bb5-82f1-55cb5163d73712017-08-11

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 13 · 245 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BMNP Nat PhosNATRUM PHOSPHORICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro5a581272-69f3-fd52-e063-6394a90a1de42026-08-31WarningsExact identifier
unii: 70WT22SF4B
RenflexisINFLIXIMABOrganon LLCdbf738c4-3fac-4422-a9d8-51d9c83a87892026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761054
rxcui: 1927285
rxcui: 1927290
unii: B72HH48FLU
Rohto Max StrengthNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companye4b49550-1ca3-4bd7-854d-409b53fa5e262026-08-20WarningsExact identifier
unii: 6OZP39ZG8H
ZYMFENTRAINFLIXIMAB-DYYBCELLTRION USA Inc.93a193ab-9f96-4da6-aa7c-31212e81879a2026-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: B72HH48FLU
CALMS FORTEAVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, AND PASSIFLORA INCARNATA FLOWERHyland's Inc.63ce9942-a299-4d9b-b63b-35b297472dc92026-08-13WarningsExact identifier
unii: 70WT22SF4B
Isopathic Phenolic RingsHOMEOPATHIC LIQUIDEnergetix Corporation98a7ca26-ccb7-43c7-bd65-892fcbacc8822026-08-11WarningsExact identifier
unii: C151H8M554
Lipo-ChordACETICUM AC, ACETYLSAL AC, ADRENOCORTICOTROPHIN, ALUMINA, ARSENICUM ALB, BORAGO, CEANOTHUS, CHELIDONIUM MAJ, CHIONANTHUS, CHLORAMPHENICOLUM, CHLORPROMAZINUM, CHOLESTERINUM, CORTISONE ACETICUM, DAMIANA, FOLLICULINUM, FUMARICUM AC, KALI IOD, LYCOPODIUM, NAT SULPHURICUM, NUX VOM, OLEUM MORRHUAE, PETROLEUM, PHENACETINUM, PHOSPHORICUM AC, PHOSPHORUS, PLUMB MET, SACCHARUM OFF, SILICEA, TARAXACUM, THYROIDINUM.Energetix Corporation5c83cbd5-46fb-48a0-a739-ff9c81e7129c2026-08-11WarningsExact identifier
unii: C151H8M554
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: 70WT22SF4B
INFLECTRAINFLIXIMAB-DYYBPfizer Laboratories Div Pfizer Inc37eaca10-d812-48bc-8b8e-b836bfa9968f2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: B72HH48FLU
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
AVSOLAINFLIXIMAB-AXXQAmgen, Incde34bcb7-b524-45c8-9181-61c6f48d540e2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: B72HH48FLU
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 70WT22SF4B
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 593YOG76RN
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 593YOG76RN
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 593YOG76RN
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
unii: 6OZP39ZG8H
BM BIO24 ICING SUGARCALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOSTotal Operations Management LLC DBA:Bestmade Natural Products Micro544b2bf9-74e8-297f-e063-6394a90a3dac2026-06-15WarningsExact identifier
unii: 70WT22SF4B
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: 70WT22SF4B
BM BM213CARBO VEG, GRAPHITES, NAT PHOS, NAT SULPH, RHUS TOXTotal Operations Management LLC DBA:Bestmade Natural Products Micro54396b10-a115-5b4f-e063-6394a90a52412026-06-14WarningsExact identifier
unii: 70WT22SF4B

Reported adverse events (FAERS/openFDA)#

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