NDC 71274-350-01 - Ruconest

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: 71274-350
Requested NDC: 71274-350-01
Package NDCs from labels: 71274-350-01, 71274-350-02
Manufacturer: Tjoapack Netherlands BV
Effective date: 2022-10-24
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Ruconest - Tjoapack Netherlands BV	Tjoapack Netherlands BV	2022-10-24	HUMAN PRESCRIPTION DRUG LABEL
Ruconest - Pharming Healthcare Inc.	Pharming Healthcare Inc.	2020-04-30	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71274-350-01	Ruconest	1 in 1 VIAL, SINGLE-USE	INJECTION, POWDER, FOR SOLUTION	1		3
71274-350-02	Ruconest	1 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71274-350	RUCONEST (C1 ESTERASE INHIBITOR RECOMBINANT) INJECTION, POWDER, FOR SOLUTION [PHARMING HEALTHCARE INC.]	3	Current NDC, Legacy NDC, 2 package rows	20200605_66d3fecb-32a4-7781-e053-2a91aa0a83ca.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71274-350-01	EA - Each	71274-350	75bf7928-924b-4edb-ba6c-81060b02cde0	1	2018-08-13
71274-350-02	EA - Each	71274-350	617c2e53-4a5d-47ee-b036-8570cd793710	1	2018-08-13

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 6 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Grain and Seed Antigens	AMARANTH, BAMBOO, BARLEY, BUCKWHEAT, CORN, FLAX SEED, LENTILS, MILLET, MILO, OAT, POPPY SEED, RICE, RYE, SESAME, SOYBEAN, SUGARCANE, SUNFLOWER SEED, WHEAT, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SULPHUR	BioActive Nutritional, Inc.	36ce44a5-e5ac-4eea-b76d-424dcd4e6b07	2023-06-20	Warnings	Exact identifier unii: C151H8M554
Saccharum officinale	SUCROSE	Boiron	6858f374-8549-4b00-e053-2991aa0a5c3c	2023-02-20		Exact identifier unii: C151H8M554
Saccharum Officinale	SACCHARUM OFFICINALE	Hahnemann Laboratories, INC.	f04b0ab3-af1c-ec2d-e053-2995a90a7855	2023-01-27		Exact identifier unii: C151H8M554
Chip Cravings	COUMARINUM, QUERCETIN, RUTIN, BAMBOO, BARLEY, POPPY SEED, CORN (ZEA MAYS), FLAX SEED (LINUM USITATISSIMUM), BUCKWHEAT (FAGOPYRUM ESULENTUM), MILLET, MILO, OAT, RICE, RYE, LENTILS, SESAME, AMARANTH, SOYBEAN, SUGARCANE (SACCHARUM OFFICINALE), SUNFLOWER SEED, WHEAT, AMARANTH, AVENA SATIVA, NATRUM SULPHURICUM, SARCOLACTICUM ACIDUM, TRITICUM REPENS, ADRENOCORTICOTROPHIN, SYCOTIC CO BACILLUS	Dr. Donna Restivo DC	719ef104-88f3-4db5-9c3a-1ac9a1a63c26	2023-01-10	Warnings	Exact identifier unii: C151H8M554
ebd482fb-dd8a-6296-e053-2a95a90ad5e1			3cf4c3f5-5230-277e-e054-00144ff8d46c	2022-10-24	Warnings, Adverse reactions	Exact identifier spl id: ebd482fb-dd8a-6296-e053-2a95a90ad5e1 spl set id: 3cf4c3f5-5230-277e-e054-00144ff8d46c
Addiclenz	BETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	Deseret Biologicals, Inc.	e39235ea-2a2f-44a7-92d6-fb1d428ebabd	2022-05-12	Warnings	Exact identifier unii: 1Q73Q2JULR
ACD-A	ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A	Fenwal, Inc.	22805f0d-ba58-41ea-b245-19980abcda22	2022-02-11		Exact identifier unii: 1Q73Q2JULR
TH-101	CALC CARB, CARBO VEG, CHELIDONIUM MAJ, COQ10, FUCUS, GRAPHITES, HOMEOPATHIC GLYCOPROTEIN COMPLEX, HYPOTHALAMUS, KALI PHOS, LYCOPODIUM, MAG PHOS, NAT MUR, NAT PHOS, NUX VOM, ORNITHOGALUM, PHYTOLACCA, PITUITARUM, PLACENTA, SINAPIS ARV FLOS, QUERCUS GLAND SP, QUERCUS ROB	Temple Health Nutrition, LLC	d54bb860-560c-4f8f-9aea-a0b7774cc92b	2021-12-29	Warnings	Exact identifier unii: C151H8M554
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9a61f1ae-d3a4-68d7-e053-2a95a90a4333	2020-12-03	Warnings	Exact identifier unii: C151H8M554
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9aefc830-329c-5e35-e053-2a95a90a6ffe	2020-11-30	Warnings	Exact identifier unii: C151H8M554
Food Additives	IRIS VERSICOLOR, SOLIDAGO VIRGAUREA, ACONITUM NAPELLUS, AGARICUS MUSCARIUS, ALLIUM CEPA, ALLIUM SATIVUM, ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BOVISTA, CAFFEINUM, CAPSICUM ANNUUM, CINCHONA OFFICINALIS, CINNAMOMUM, COCCUS CACTI, CYNARA SCOLYMUS, FRAGARIA VESCA, GELSEMIUM SEMPERVIRENS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, JEQUERITY, JUGLANS REGIA, LACHESIS MUTUS, LEDUM PALUSTRE, LYCOPODIUM CLAVATUM, MENTHA PIPERITA, NATRUM MURIATICUM, NUX MOSCHATA,	Newton Laboratories, Inc.	9af2d6f4-baa8-5da9-e053-2995a90a3dac	2020-11-30	Warnings	Exact identifier unii: C151H8M554
GUNA FLAM RELIEF	ACONITUM NAPELLUS - APIS MELLIFERA - ARNICA MONTANA WHOLE - ATROPA BELLADONNA - BASIC CUPRIC CARBONATE - BRYONIA ALBA ROOT - MATRICARIA CHAMOMILLA WHOLE - CALCIUM SULFIDE - CITRIC ACID MONOHYDRATE - ECHINACEA ANGUSTIFOLIA - FERRIC PHOSPHATE - PHYTOLACCA AMERICANA ROOT - RANCID BEEF - SODIUM PYRUVATE - PORK LIVER - RANCID BEEF - SUS SCROFA PITUITARY GLAND -	Guna spa	af5a9c74-e1c7-6574-e053-2995a90a3d10	2020-09-15	Warnings	Exact identifier unii: 2968PHW8QP
Ruconest	C1 ESTERASE INHIBITOR RECOMBINANT	Pharming Healthcare Inc.	66d3fecb-32a4-7781-e053-2a91aa0a83ca	2020-04-30	Warnings, Adverse reactions	Exact identifier application number: BLA125495 ndc (package): 71274-350-01 ndc (package): 71274-350-02 ndc (product): 71274-350 ndc11 (package): 71274035001 rxcui: 1599836 rxcui: 1599841 spl id: a742815a-7705-9153-e053-2995a90a562d spl set id: 66d3fecb-32a4-7781-e053-2a91aa0a83ca unii: 5QS67N4551
GUNA-ALLERGY-PREV	AMBROSIA ARTEMISIIFOLIA - ANGUILLA ROSTRATA BLOOD SERUM - ARUNDO PLINIANA ROOT - BLACK CURRANT - CHELIDONIUM MAJUS - CITRIC ACID MONOHYDRATE - HISTAMINE DIHYDROCHLORIDE - HUMAN INTERLEUKIN 12 - INTERFERON GAMMA-1B - MANGANESE GLUCONATE - PARIETARIA OFFICINALIS - PHLEUM PRATENSE - SODIUM PYRUVATE - SODIUM SULFATE - SUCCINIC ACID - SULFUR - URTICA URENS - VIBURNUM OPULUS ROOT - WYETHIA HELENIOIDES ROOT -	Guna spa	adae93c0-1de9-4e45-ab58-148171f0dc86	2018-12-21	Warnings	Exact identifier unii: 2968PHW8QP
Additox	TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BELLADONNA, CHELIDONIUM MAJUS, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	BioActive Nutritional, Inc.	319ee2fe-58e3-495e-bf0d-df201f6fbb1c	2018-07-18	Warnings	Exact identifier unii: 1Q73Q2JULR

Reported adverse events (FAERS/openFDA)#

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