NDC 0169-7955 - REBINYN

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: 0169-7955
Package NDCs from labels: 0169-7955-11, 0169-7955-90
Manufacturer: Novo Nordisk
Effective date: 2022-08-11
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
REBINYN - Novo Nordisk	Novo Nordisk	2022-08-11	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0169-7955-11	REBINYN	4 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	4 mL	125 [iU] in 1mL	9
0169-7955-90	REBINYN	4 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	4 mL	125 [iU] in 1mL	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0169-7955	REBINYN (COAGULATION FACTOR IX RECOMBINANT, GLYCOPEGYLATED) KIT [NOVO NORDISK]	9	Unmatched	20240808_0ea37235-35fd-410d-b8c4-40ba15fe1294.zip

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 35 of 46 · 920 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
A04 DEEP ANTITOX	ALLIUM CEPA, ALLIUM SATIVUM, ALOE SOCOTRINA, ARSENICUM IODATUM, ASTERIAS RUBENS, BAPTISIA TINCTORIA, CALCAREA IODATA, CANDIDA ALBICANS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, CINA, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, INDOLUM, LAC VACCINUM, LACTICUM ACIDUM, MILLEFOLIUM, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SCROPHULARIA NODOSA, SKATOLUM, SOLIDAGO VIRGAUREA, SULPHUR, URICUM ACIDUM	Apex Energetics Inc.	b9bbbddf-b822-4780-e053-2a95a90afbba	2024-01-08	Warnings	Exact identifier unii: C151H8M554
B07 DPRSN ANTITOX	ADRENALINUM, AETHUSA CYNAPIUM, AGNUS CASTUS, ALFALFA, ARGENTUM NITRICUM, AURUM METALLICUM, AVENA SATIVA, CERATOSTIGMA WILLMOTTIANUM FLOWER, CHERRY PLUM FLOWER, DAMIANA, EUROPEAN ASPEN FLOWER, EUROPEAN HORNBEAM FLOWER, GORSE FLOWER, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, NATRUM MURIATICUM, PASSIFLORA INCARNATA, ROSA CANINA FLOWER, SEPIA, SWEET CHESTNUT FLOWER, THYROIDINUM, WILD MUSTARD FLOWER	Apex Energetics Inc.	bd1fbb76-4f6f-7098-e053-2a95a90ae25c	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
B13 CELL SALT COMPLEX	ALLIUM SATIVUM, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CARBO VEGETABILIS, FERRUM IODATUM, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, PHOSPHORICUM ACIDUM, URTICA URENS	Apex Energetics Inc.	bf78b0b0-5b7b-28cb-e053-2a95a90a1e7d	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
B05 GLUCO BALANCE	ADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUM	Apex Energetics Inc.	bae9ff7e-eb69-c61d-e053-2995a90a2627	2024-01-08	Warnings	Exact identifier unii: C151H8M554
F01 ANGR-RLS	BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CHAMOMILE FLOWER, CHICORY FLOWER, GARLIC, ENGLISH HOLLY FLOWER, EUROPEAN BEECH FLOWER, FORKING LARKSPUR FLOWER, GERMAN CHAMOMILE FLOWER, IMPATIENS GLANDULIFERA FLOWER, LILIUM TIGRINUM, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, RUBBER RABBITBRUSH, VITIS VINIFERA FLOWER, WATERMELON, WHITE WILLOW FLOWER, YELLOW STAR THISTLE	Apex Energetics Inc.	bd0b2eab-b6eb-19ce-e053-2a95a90aebe6	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
D05 KDNY-DRN	APIS MELLIFERA, ASPARAGUS, BERBERIS VULGARIS ROOT BARK, LYTTA VESICATORIA, CHELIDONIUM MAJUS, JUNIPER BERRY, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, POPULUS TREMULOIDES BARK, RHUS AROMATICA ROOT BARK, RUBIA TINCTORUM ROOT, SAW PALMETTO, SOLIDAGO VIRGAUREA FLOWERING TOP, TARAXACUM OFFICINALE, AND ARCTOSTAPHYLOS UVA-URSI LEAF	Apex Energetics Inc.	146800dc-bb1a-4d4c-803a-156a9fba600d	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
F02 ANGR-FLX	ADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLE	Apex Energetics Inc.	bc7c2bf3-8b0d-766f-e053-2a95a90ad34c	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
F19 STRNG-MND	ANACARDIUM ORIENTALE, ARNICA MONTANA, AURUM METALLICUM, CASTANEA SATIVA, CITRUS SINENSIS, CRATAEGUS MONOGYNA, CYTISUS SCOPARIUS, DANDELION, FAGUS SYLVATICA, FUCHSIA, GORSE, HYDRASTIS CANADENSIS, IGNATIA AMARA, IRON, KALI PHOSPHORICUM, MALUS SYLVESTRIS, NATRUM MURIATICUM, PAEONIA CALIFORNICA, POMEGRANATE, PRUNELLA VULGARIS, ROSA CALIFORNICA, SINAPIS ARVENSIS, YARROW, YERBA SANTA	Apex Energetics Inc.	bec4e5d7-d968-175b-e053-2a95a90a4e0a	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
F22 SOMATICA	AGRIMONY, CALOCHORTUS TOLMIEI, CIMICIFUGA RACEMOSA, CLEMATIS VITALBA, DANDELION, DIPLACUS AURANTIACUS, ECHINACEA ANGUSTIFOLIA, EHRENDORFERIA CHRYSANTHA, FUCHSIA, HYDRASTIS CANADENSIS, KALI PHOSPHORICUM, LARIX DECIDUA, LATHYRUS ODORATUS, LONICERA CAPRIFOLIUM, NATRUM MURIATICUM, ROSA CALIFORNICA, ROSMARINUS OFFICINALIS, STIGMATA MAIDIS, SULPHUR, YARROW, YERBA SANTA	Apex Energetics Inc.	bed99bed-3902-5278-e053-2a95a90aeab6	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
F27 MVON	AGRIMONY, ARNICA MONTANA, ARSENICUM ALBUM, ARTEMISIA TRIDENTATA, ASPEN, CHAMOMILE, CHICORY, DICENTRA FORMOSA, EHRENDORFERIA CHRYSANTHA, EUCALYPTUS GLOBULUS, HARDY FUCHSIA, HORSE CHESTNUT, IGNATIA AMARA, JUGLANS REGIA, LACHESIS MUTUS, LARIX DECIDUA, MIMULUS GUTTATUS, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, PALLADIUM, PERFOLIATE HONEYSUCKLE, PETUNIA AXILLARIS, PULSATILLA VULGARIS, PYRENEES STAR OF BETHLEHEM, SCOTCH BROOM, TRILLIUM CHLOROPETALUM, YELLOW JASMINE, YERBA SANTA, ZINNIA ELEGANS	Apex Energetics Inc.	bca69508-0934-ecfc-e053-2995a90a0ce3	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
F26 PRSVR	ALLIUM CEPA WHOLE, APIS MELLIFICA, AURUM METALLICUM, BORAGE, BROMUS RAMOSUS, CALIFORNIA WILDROSE WHOLE, ENGLISH ELM ING TWIG, ENGLISH HAWTHRON, ENGLISH OAK, EUROPEAN HORNBEAM, EUROPEAN OLIVE, GENTIANELLA AMARELLA, GORSE, LARIX DECIDUA, LUFFA OPERCULATA, MERCURIUS SOLUBILIS, MULLEIN, NATRUM MURIATICUM, PENSTEMON DAVIDSONII WHOLE, PLATINUM METALLICUM, PULSATILLA VULGARIS, PURPLE LOOSESTRIFE WHOLE, ROSA CHINENSIS, SCOTCH BROOM, SEPIA, WILD MUSTARD, YERBA SANTA, ZINCUM METALLICUM	Apex Energetics Inc.	beaef254-bf57-df92-e053-2995a90abd65	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
G05 OXI-MET	ADENOSINE TRIPHOSPHATE, IGNATIA AMARA, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, SULPHUR	Apex Energetics Inc.	beb18213-911a-38d4-e053-2a95a90ac17c	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
LIVER PLUS Formula	ADENOSINE TRIPHOSPHATE, IGNATIA AMARA, KALI PHOSPHORICUM, NATRUM MURIATICUM, NUX VOMICA, SULPHUR	Apex Energetics Inc.	d8c7b349-8718-d8ed-e053-2995a90ae988	2024-01-08	Warnings	Exact identifier unii: 451W47IQ8X
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	037ac04d-f8f3-4bb8-993a-ac8f7683ff83	2024-01-04	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sinus HP	ARSENICUM ALBUM, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, THUJA OCCIDENTALIS	Energique, Inc.	3cdddbe5-e3d2-4629-a045-868e18183f1d	2023-12-19	Warnings	Exact identifier unii: 451W47IQ8X
BSS	BALANCED SALT SOLUTION	Alcon Laboratories, Inc.	28488c7b-cf6a-4a03-916f-cc66b3afdc57	2023-12-14	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Altachlore Sodium Chloride Hypertonicity	SODIUM CHLORIDE	Altaire Pharmaceuticals Inc.	dc0d94d8-4475-4956-8ded-bdb9496074e4	2023-12-09	Warnings	Exact identifier unii: 451W47IQ8X
terrasil Eczema and Psoriasis Severe Outbreak	GRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIG	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	4d7128fb-57f1-4d0d-a83a-daef40928ecd	2023-11-30	Warnings	Exact identifier unii: 451W47IQ8X
terragen HG Formula Maximum Strength	GRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIG	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	e632c831-e25d-4d04-ba72-2327d25713b1	2023-11-30	Warnings	Exact identifier unii: 451W47IQ8X
Femstat C	ECHINACEA (ANGUSTIFOLIA), FUCUS VESICULOSUS, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, KREOSOTUM, NATRUM MURIATICUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), SEPIA	Energique, Inc.	420119ca-f2bf-40e3-9e40-00498724c228	2023-11-30	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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