NDC 71202-004-03 - 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: 71202-004
Requested NDC: 71202-004-03
Package NDCs from labels: 71202-004-03, 71202-004-04
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
71202-004-04	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 44 of 48 · 956 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dr. Talbots Gas Colic Relief	CARBO VEGETABILIS, CHAMOMILLA, FOENICULUM VULGARE, LYCOPODIUM, NUX MOSCHATA, RAPHANUS SATIVUS, ZINGIBER OFFICINALE, KALI MURIATICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM	Talbot's Pharmaceuticals Family Products, LLC	91213655-92d2-64c2-e053-2995a90aaa5a	2021-10-05	Warnings	Exact identifier unii: 70WT22SF4B
Dr. Talbots Tummy Ache Relief	CALENDULA OFFICINALIS, CARBO VEGETABILIS, CHAMOMILLA, FOENICULUM VULGARE, LYCOPODIUM, NUX MOSCHATA, ZINGIBER OFFICINALE, KALI MURIATICUM, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM	Talbot's Pharmaceuticals Family Products, LLC	91c1e0ae-9999-0ae2-e053-2995a90a2d71	2021-10-05	Warnings	Exact identifier unii: 70WT22SF4B
Solucion InterSol	SOLUCION ADITIVA PARA PLAQUETAS 3	Fenwal, Inc.	d5eaf5f4-67d3-4475-af9a-f5b0f882f5d1	2021-10-04	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: 593YOG76RN
NATRUM MURIATICUM	NATRUM MURIATICUM	Rxhomeo Private Limited d.b.a. Rxhomeo, Inc	520edb18-5f2a-4448-ba53-83408a839e1f	2021-09-02	Warnings	Exact identifier unii: 451W47IQ8X
Lactated Ringers Irrigation	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE	B. Braun Medical Inc.	0db56c7a-2b8f-4593-8591-2c481c92b2cf	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride for Irrigation	SODIUM CHLORIDE FOR IRRIGATION	B. Braun Medical Inc.	5bd9b176-0402-4a3f-a6b4-c3f393fc092a	2021-08-06	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Phosphates	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	Fresenius Kabi USA, LLC	e6169d3b-39d2-47f9-8d5b-b53ec069a722	2021-07-23	Warnings, Adverse reactions	Exact identifier unii: 593YOG76RN
0.9% SODIUM CHLORIDE	SODIUM CHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	c755e41b-acba-7234-e053-2995a90aff0f	2021-07-17	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Melange combination	CALCAREA SULPHURICA, CALCIUM PHOSPHORICUM, KALI MURIATICUM, KALIUM PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRIUM SULFURICUM, CALCAREA FLUORICA, FERRUM PHOSPHORICUM, SILICEA	Seroyal USA	0a071fbf-0075-4479-e054-00144ff8d46c	2021-07-14	Warnings	Exact identifier unii: 451W47IQ8X unii: 70WT22SF4B
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	4a655cde-283f-4ec8-a3d9-5f539c55c204	2021-05-10	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	ed8fd0c1-ac42-4267-877e-ceadf3831c90	2021-04-29	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dr. Talbots Vital 12	CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEA, ZINC GLUC	Talbot's Pharmaceuticals Family Products, LLC	c10bb804-8169-63da-e053-2a95a90a8306	2021-04-28	Warnings	Exact identifier unii: 451W47IQ8X unii: 70WT22SF4B
Dr. Talbots Infant Daily Allergy Relief	ALLIUM CEPA, ARALIA RACEMOSA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, LUFFA OPERCULATA, PULSATILLA, SOLIDAGO, NATRUM MURIATICUM	Talbot's Pharmaceuticals Family Products, LLC	c0963200-67dd-6349-e053-2a95a90adde1	2021-04-22	Warnings	Exact identifier unii: 451W47IQ8X
CLINIMIX E	LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE	Baxter Healthcare Company	8469d6fb-d6ef-476f-8cc3-0905192de0a8	2021-04-13	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Medical Purchasing Solutions, LLC	c3f8e83c-4fb9-91da-e053-2a95a90abd63	2021-04-12	Adverse reactions	Exact identifier unii: 451W47IQ8X
CVS Health Sterile Saline Mist Live Better	SODIUM CHLORIDE	CVS Pharmacy	ccc3ab8c-b22f-420d-869b-f2a65b8c7180	2021-03-13	Warnings	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	aeaed9cb-b629-4019-88d2-a916179427de	2021-02-19	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
GUNA KIDNEY PLUS	CALCIUM SULFIDE - CHONDRODENDRON TOMENTOSUM ROOT - EQUISETUM HYEMALE - SUS SCROFA PITUITARY GLAND - APIS MELLIFERA - URTICA URENS - SODIUM CHLORIDE - LOBARIA PULMONARIA - HORSE CHESTNUT - BERBERIS VULGARIS FRUIT - SOLIDAGO VIRAGAUREA FLOWERING TOP -	Guna spa	b8dacd94-8da1-4a8d-e053-2995a90acb67	2021-02-04	Warnings	Exact identifier unii: 451W47IQ8X
Candid- Y	ADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.	Newton Laboratories, Inc.	c68c9c20-3a07-16df-e053-2a95a90a0cbc	2021-02-01	Warnings	Exact identifier unii: 70WT22SF4B
Candid-Y	ADRENALINUM, CANDIDA ALBICANS, THYROIDINUM, TORULA CEREVISIAE, TRITICUM, USTILAGO MAIDIS, ANTIMON. CRUD, ARSENICUM ALB., BAPTISIA, BERBER. AQUI., BRYONIA, CALC. PHOS., CINCHONA, HELONIAS DIOICA, HYDRASTIS, IODIUM, IRIS VERSICOLOR, KALI CARB., LACHESIS, LYCOPODIUM, MERC. VIV., NAT.CARB., NAT. PHOS, NITRICUM AC., PHOSPHORUS, PODOPH. PELT, PULSATILLA, SEPIA, ECHINACEA, GINKGO, JUGLANS REGIA, LAPPA, THUJA OCC.	Newton Laboratories, Inc.	c68ea9c3-f95c-dbcd-e053-2995a90a9aeb	2021-02-01	Warnings	Exact identifier unii: 70WT22SF4B

Reported adverse events (FAERS/openFDA)#

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