FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
REBINYN - Novo NordiskNovo Nordisk2022-08-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-7955-11REBINYN4 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,4 mL125 [iU] in 1mL9
0169-7955-90REBINYN4 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,4 mL125 [iU] in 1mL9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-7955REBINYN (COAGULATION FACTOR IX RECOMBINANT, GLYCOPEGYLATED) KIT [NOVO NORDISK]9Unmatched20240808_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 38 of 46 · 920 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Grain and Seed AntigensAMARANTH, 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, SULPHURBioActive Nutritional, Inc.36ce44a5-e5ac-4eea-b76d-424dcd4e6b072023-06-20WarningsExact identifier
unii: C151H8M554
unii: 451W47IQ8X
Vital Skin Hair NailsL-ALANINE, L-ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, APIS MELLIFICA, BIOTIN, EPIDERMIS SUIS, GALIUM APARINE, HAMAMELIS VIRGINIANA, HEPAR SUIS, HGH, HYPOPHYSIS SUIS, NATRUM MURIATICUM, PANTOTHENIC ACID, PHOSPHORICUM ACIDUM, RIBOFLAVINUM, THUJA OCCIDENTALISLiddell Laboratories, Inc.3e8a9233-6e65-4023-b3f8-8bca369a9c2a2023-06-15WarningsExact identifier
unii: 451W47IQ8X
unii: 4QD397987E
Endopar FCIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, OOPHORINUM (SUIS), HYPOPHYSIS SUIS, THYROIDINUM (SUIS), GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), SEPIAEnergique, Inc.d186ae0e-0dc3-48e7-9e22-6778bb80ad182023-06-07WarningsExact identifier
unii: 451W47IQ8X
Cyclease PMSESTRONE, SODIUM CHLORIDE, SEPIA OFFICINALIS JUICELaboratoires Boiron09ff0633-2992-4aba-96ed-45a69f3ee5892023-05-30WarningsExact identifier
unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEMedical Purchasing Solutions, LLC8a0d24a9-d02a-0379-e053-2a95a90af7122023-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDESEnergique, Inc.00478787-ccec-4101-a0da-fd337037c3ee2023-05-12WarningsExact identifier
unii: 451W47IQ8X
Natrum MuriaticumNATRIUM MURIATICUMTrue Botanica, LLC7d2d9129-8683-484d-e053-2a91aa0a6f8f2023-05-01WarningsExact identifier
unii: 451W47IQ8X
CosmestatALFALFA, AVENA SATIVA, IODIUM, BOVISTA, FORMALINUM, HYPOPHYSIS SUIS, MANGANUM ACETICUM, NATRUM MURIATICUM, PETROLEUM, PULSATILLA (PRATENSIS), RHUS TOX, TEREBINTHINA, THYROIDINUM (BOVINE), CORTISONE ACETICUMEnergique, Inc.edc8eb65-84b3-433f-8aad-7a741f5637182023-04-17WarningsExact identifier
unii: 451W47IQ8X
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: 451W47IQ8X
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: 451W47IQ8X
GlutenstatALFALFA, ZINGIBER OFFICINALE, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, BARLEY (GRAIN), CARBO VEGETABILIS, GLYPHOSATE, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, OAT (GRAIN), PULSATILLA (VULGARIS), RYE (GRAIN), WHEAT (GRAIN), GLUTENEnergique, Inc.c6b867b6-74d9-4725-90d7-7d5d1fe611212023-04-05WarningsExact identifier
unii: 451W47IQ8X
AnxietyBORAX, NATRUM MURIATICUM, CAUSTICUM, ELETTARIA CARDAMOMUM, PLUMBUM METALLICUM, SEPIA, LILIUM TIGRINUM, OXYTROPIS LAMBERTIINutritional Specialties, Inc.657ed32f-3ac7-4806-96b4-4c7aa0f65e7f2023-04-03WarningsExact identifier
unii: 451W47IQ8X
Virility LiquescenceAVENA SATIVA, DAMIANA, BERBERIS VULGARIS, EPIMEDIUM GRANDIFLORUM, GLYCERINUM, SABAL SERRULATA, IODIUM, LECITHIN, FERRUM MURIATICUM, NATRUM MURIATICUM, AGNUS CASTUS, BUFO RANA, CINCHONA OFFICINALIS, HUMAN GROWTH HORMONE (HGH), ORCHITINUM (BOVINE), PHOSPHORICUM ACIDUM, PHOSPHORUS, SELENIUM METALLICUM, ZINCUM VALERIANICUM, OOPHORINUM (SUIS), SEPIANutritional Specialties, Inc.81cc3e2b-f95e-4ba4-a15f-c07b4def0e2f2023-03-29WarningsExact identifier
unii: 451W47IQ8X
Spleen Thymus LiquescenceCINCHONA OFFICINALIS, QUERCUS GLANDIUM SPIRITUS, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), THYMUS (BOVINE), CHININUM ARSENICOSUM, NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.bc1cc31e-0e8a-49a2-9654-f00eaa72fc042023-03-24WarningsExact identifier
unii: 451W47IQ8X
MannitolMANNITOLFresenius Kabi USA, LLCc395e13d-6ea1-4104-8b37-669cfb982f042023-03-16Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Saccharum officinaleSUCROSEBoiron6858f374-8549-4b00-e053-2991aa0a5c3c2023-02-20Exact identifier
unii: C151H8M554
Natrum muriaticumSODIUM CHLORIDEBoiron1ef4a040-7bee-11e6-8371-424c583030312023-02-20Exact identifier
unii: 451W47IQ8X
Natrum muriaticumSODIUM CHLORIDEBoiron8645e304-a71b-5cba-e053-2a91aa0a2d882023-02-20Exact identifier
unii: 451W47IQ8X
EyeClear ProCALC CARB, CALC FLUOR, CAUSTICUM, CINERARIA, EUPHRASIA, NAPHTHALINUM, NAT MUR, PHOS, QUASSIA, SILICEASilver Star Brandsf4d4943b-cb78-aa71-e053-2a95a90ac6382023-02-16WarningsExact identifier
unii: 451W47IQ8X
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.29d821ff-389c-41fb-8a27-89bd3f022b822023-02-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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