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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0006-4305-02	2025-01-30	C162847	48780-1	f386c649-e6fb-0266-e053-dadaa90a7c1a	These 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
0006-4305-02	2023-02-03	C162847	48780-1	f386c649-e6fb-0266-e053-dadaa90a7c1a	These 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
0006-4305-02	2023-01-30	C162847	48780-1	f386c649-e6fb-0266-e053-dadaa90a7c1a	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
0006-4305-01	Renflexis	1 in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	1		14
0006-4305-02	Renflexis	1 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	1		14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0006-4305	RENFLEXIS (INFLIXIMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MERCK SHARP & DOHME LLC]	14	Legacy NDC, 2 package rows	20230204_3827e1be-f328-45f7-b113-311b57039f8c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0006-4305-01	EA - Each	0006-4305	1610e94a-cf30-4667-b4ea-b6bd43075da3	1	2017-08-11
0006-4305-02	EA - Each	0006-4305	d0969126-a49f-4bb5-82f1-55cb5163d737	1	2017-08-11

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 2 of 13 · 243 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BM BM38 DROPS	BERB AQUI, GRAPHITE, HYDROCOTYLE, KALI BROM, KALI IODAT, NATRUM PHOS, SULPHUR IODAT	Total Operations Management LLC DBA:Bestmade Natural Products Micro	5410af95-519a-f0d5-e063-6294a90ac0cf	2026-06-12	Warnings	Exact identifier unii: 70WT22SF4B
BM BM38 DROPS	BERB AQUI, GRAPHITE, HYDROCOTYLE, KALI BROM, KALI IODAT, NATRUM PHOS, SULPHUR IODAT	BM Private Limited	53f8163d-28c3-b3b3-e063-6394a90a86da	2026-06-11	Warnings	Exact identifier unii: 70WT22SF4B
Jacksons Cell Salts DIGESTIVE BALANCE	NAT MUR, NAT PHOS, NAT SULPH	Zettl Health Inc.	54018d0e-372f-8afc-e063-6394a90aeb15	2026-06-11	Warnings	Exact identifier unii: 70WT22SF4B
Jacksons Cell Salts 5 IN 1 PHOS	CALC PHOS, FERRUM PHOS , KALI PHOS, MAG PHOS, NAT PHOS	Zettl Health Inc.	53e85f92-5863-82f1-e063-6394a90af52e	2026-06-10	Warnings	Exact identifier unii: 70WT22SF4B
BM BIO28 ALCOHOL	CALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEA	BM Private Limited	53d1c51a-77eb-bb3c-e063-6394a90aab3f	2026-06-09	Warnings	Exact identifier unii: 70WT22SF4B
BM BIO24	CAL PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT PHOS.	Total Operations Management LLC DBA:Bestmade Natural Products Micro	53d5058d-861a-9e20-e063-6294a90a164c	2026-06-09	Warnings	Exact identifier unii: 70WT22SF4B
BM Nat Phos	NATRUM PHOSPHORICUM	Total Operations Management LLC DBA:Bestmade Natural Products Micro	53bacdaf-d7c8-9ae9-e063-6294a90a898c	2026-06-08	Warnings	Exact identifier unii: 70WT22SF4B
Scrofularoforce	RUMEX CRISPUS, XANTHOXYLUM FRAXINEUM, LYMPH NODE (SUIS), SCROPHULARIA NODOSA, BARYTA CARBONICA, BARYTA MURIATICA, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, HELLEBORUS NIGER, IODIUM, KALI PHOSPHORICUM, LACHESIS MUTUS, NATRUM PHOSPHORICUM, SILICEA, JUNIPERUS VIRGINIANA	BioActive Nutritional, Inc.	737cd410-0405-41b0-b7f2-29bb20037849	2026-06-08	Warnings	Exact identifier unii: 70WT22SF4B
BM Nat Phos Icing Sugar	NATRUM PHOSPHORICUM ICING SUGAR	Total Operations Management LLC DBA:Bestmade Natural Products Micro	5356e3a2-11f9-98e5-e063-6294a90a08eb	2026-06-03	Warnings	Exact identifier unii: 70WT22SF4B
BM NAT PHOS POTENCY	NAT PHOS	BM Private Limited	53239eb6-1403-619c-e063-6394a90a4958	2026-05-31	Warnings	Exact identifier unii: 70WT22SF4B
BM BM213	CARBO VEG, GRAPHITES, NAT PHOS, NAT SULPH, RHUS TOX	BM Private Limited	52cca143-b5cd-e1d9-e063-6394a90a5b15	2026-05-27	Warnings	Exact identifier unii: 70WT22SF4B
Sodium Phosphates	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	Hospira, Inc.	6f044d16-295e-43ff-72a3-b045c387bc5c	2026-05-11	Warnings, Adverse reactions	Exact identifier unii: 593YOG76RN
Quantum Resonance	ALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUM	Deseret Biologicals, Inc.	f94a10bd-1c40-42c7-b458-b58070614549	2026-04-10	Warnings	Exact identifier unii: 70WT22SF4B
Quantum Resonance	ALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUM	Deseret Biologicals, Inc.	1467111a-bef6-473d-b7f2-3309a9bb72ce	2026-04-10	Warnings	Exact identifier unii: 70WT22SF4B
Connection	ANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALIS	Deseret Biologicals, Inc.	4a8be3aa-9bd9-4bb1-af98-a940c13b2bd0	2026-04-10	Warnings	Exact identifier unii: C151H8M554
Connection	ANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA, GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALIS	Deseret Biologicals, Inc.	214eb19a-e7a2-421c-9f34-724ce430185c	2026-04-10	Warnings	Exact identifier unii: C151H8M554
Dibasic Sodium Phosphate, Monobasic Potassium Phosphate and Monobasic Sodium Phosphate	DIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATE	Rising Pharma Holdings, Inc.	b01eac95-dbe3-4b21-a922-187e0fc8ad23	2026-04-07	Adverse reactions	Exact identifier unii: 593YOG76RN
Buffer pH	CHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIA	NaturalCare	2161a2e2-613d-4dac-a5f6-796d40e849d9	2026-03-25	Warnings	Exact identifier unii: 70WT22SF4B
PHOSPHA 250 NEUTRAL	DIBASIC SODIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE AND MONOBASIC SODIUM PHOSPHATE	Rising Pharma Holdings, Inc.	9432adfc-6add-4ab4-ae93-2e2daf348be2	2026-03-25	Adverse reactions	Exact identifier unii: 593YOG76RN
BM BIO7	CALC PHOS, FERR PHOS, KALI PHOS, NAT PHOS, NAT SULF.	BM Private Limited	4d260c2a-9218-17d0-e063-6394a90a62b7	2026-03-16	Warnings	Exact identifier unii: 70WT22SF4B

Reported adverse events (FAERS/openFDA)#

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