NDC 71202-003-03 - Eticovo

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: 71202-003
Requested NDC: 71202-003-03
Package NDCs from labels: 71202-003-03, 71202-003-04
Manufacturer: Samsung Bioepis Co., Ltd. | PPD Development Ireland Ltd.
Effective date: 2019-05-07
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Eticovo - Samsung Bioepis Co., Ltd. \| PPD Development Ireland Ltd.	Samsung Bioepis Co., Ltd. \| PPD Development Ireland Ltd.	2019-05-07	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71202-003-04	2021-01-29	C162847	48780-1	ba0f9c33-1cc4-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use Eticovo safely and effectively. See full prescribing information for Eticovo. Eticovo (etanercept-ykro) injection, for subcutaneous use Initial U.S. Approval: 2019 Eticovo (etanercept-ykro) 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 differences betwee

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 50 of 52 · 1,021 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEXTROSE AND SODIUM CHLORIDE	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE	Fresenius Kabi USA, LLC	b825c9c4-f2fb-4a4a-9d8c-fb020ad07e93	2020-04-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a2b8220f-e33a-51c3-e053-2995a90a0734	2020-04-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
0.9% SODIUM CHLORIDE	0.9% SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	a2bba76a-08ce-6902-e053-2995a90ab9c9	2020-04-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dextrose and Electrolyte No. 48	SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, MONOBASIC POTASSIUM PHOSPHATE, SODIUM CHLORIDE AND DEXTROSE MONOHYDRATE	Baxter Healthcare Company	b283a454-0c20-4fbf-92d3-dae1f3cd3cad	2020-02-13	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	fbc01464-8885-4075-af41-911ffec5ae92	2020-01-27	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	e41adb4e-06fb-4141-ba55-50b043f3c9da	2019-11-19		Exact identifier unii: 593YOG76RN
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	14445dfd-6041-40cd-a043-3f4da6bcb9c1	2019-11-18		Exact identifier unii: 593YOG76RN
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	2557199a-5f60-49d8-b093-1e0700211243	2019-11-18		Exact identifier unii: 593YOG76RN
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	794f724c-87f0-49c1-9b26-c9e491978313	2019-11-18		Exact identifier unii: 593YOG76RN
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	5c7d3287-883a-459b-9214-074a583c8a59	2019-11-18		Exact identifier unii: 593YOG76RN
CPDA-1	ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE	Fenwal, Inc.	448a1dc5-7a98-4b2f-82af-4b92de05cfc3	2019-11-18		Exact identifier unii: 593YOG76RN
Plasma-Lyte A	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Baxter Healthcare Corporation	6ec9e61c-2c26-402f-8604-f446b2e34058	2019-08-05	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Acid Reflux Relief	CAPSICUM, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, STRYCHNOS NUX-VOMICA SEED, ROBINIA PSEUDOACACIA BARK, SULFUR, SEPIA OFFICINALIS JUICE	Homeocare Laboratories	01ddf3ee-e925-404d-9b41-7876d5fd6634	2019-03-20	Warnings	Exact identifier unii: 70WT22SF4B
Potassium Chloride in Dextrose and Sodium Chloride	POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	Baxter Healthcare Company	c553fed1-3de5-4826-8eff-633b5923bf0b	2019-02-21	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Sodium Chloride	POTASSIUM CHLORIDE AND SODIUM CHLORIDE	Baxter Healthcare Company	becc7410-0a25-49f5-b0c3-240078479dc8	2019-01-11	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Skin Klear Acne Relief	TRIBASIC CALCIUM PHOSPHATE, FUMARIA OFFICINALIS FLOWERING TOP, ARCTIUM LAPPA ROOT, SODIUM CHLORIDE, SAPONARIA OFFICINALIS ROOT, SILICON DIOXIDE, SOLIDAGO VIRGAUREA FLOWERING TOP, SULFUR, VIOLA TRICOLOR	Homeocare Laboratories	65afbc20-611b-4bc4-a151-c633bec66a82	2018-12-31	Warnings	Exact identifier unii: 451W47IQ8X
H.M.D.	ALLIUM SAT, AVENA, BERBER VULG, LAPPA, PHYTOLACCA, SOLIDAGO, ALUMINA, ARG NIT, BARYTA CARB, BERYLLIUM, CADMIUM MET, CURPRUM MET, FLUORICUM ACIDUM, INDIUM, IODIUM, LITHIUM CARB, MERC SOLUB, NICCOLUM CARB, NITROGENUM OXYGENATUM, PLUMB MET, SELENIUM, STRONTIUM CARB, TITANIUM, ARSENICUM ALB, NAT MUR, NUX VOM	Zorex International	8c53091a-904d-4756-93e4-17143c5b48e9	2018-12-21	Warnings	Exact identifier unii: 451W47IQ8X
Candida	BAPTISIA TINCTORIA, ECHINACEA PURP, GLYCYRRHIZA GLABRA, ASTRAGALUS, CANDIDA ALB, BORAX, CALC CARB, KREOSOTUM, LYCOPODIUM, NUX VOM, PHOSPHORICUM AC, PULSATILLA, SEPIA, THUJA OCC, NAT PHOS, NITRICUM AC	Zorex International	c6595326-6d04-499e-9eb7-0a4cd2ba48fd	2018-12-21	Warnings	Exact identifier unii: 70WT22SF4B
Vitality Female	ARALIA QUINQUEFOLIA, AVENA SATIVA, BERBERIS VULGARIS, CAUSTICUM, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA	Natural Creations, Inc	679ba86d-bf84-4ded-b0bf-d55a0df9faa4	2018-12-21	Warnings	Exact identifier unii: 451W47IQ8X
Hydrate II	BERBER AQUI, BETA VULG, BOLDO, CARDUUS MAR, CHELIDONIUM MAJ, HORDEUM VULGARE, IRIS VERS, ROSMARINUS, TARAXACUM, AVENA, ELEUTHEROCOCCUS SENTICOSUS, XANTHOXYLUM, EQUISETUM HYEM, HYPERICUM, ULMUS FULV, GETTYSBURG AQUA, GLYCYRRHIZA, WILDBAD AQUA, CARLSBAD AQUA, ATP, HYDROGEN, NAT MUR, OXYGEN, SILICEA, WIESBADEN AQUA	Zorex International	e5f53495-3b75-4d7c-89af-23058fb6fd05	2018-12-21	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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