FDA.reportPublic FDA data

NDC 0169-8501 - ESPEROCT

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
0169-8501
Package NDCs from labels
0169-8501-11, 0169-8501-90
Manufacturer
Novo Nordisk | Vetter Pharma Fertigung GmbH & Co. KG
Effective date
2024-07-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ESPEROCT - Novo Nordisk | Vetter Pharma Fertigung GmbH & Co. KGNovo Nordisk | Vetter Pharma Fertigung GmbH & Co. KG2024-07-01PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0169-8501-11ESPEROCT4 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,4 mL125 [iU] in 1mL7
0169-8501-90ESPEROCT4 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,4 mL125 [iU] in 1mL7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-8501ESPEROCT (ANTIHEMOPHILIC FACTOR (RECOMBINANT), GLYCOPEGYLATED-EXEI) KIT [NOVO NORDISK]7Unmatched20240726_562f94e8-825f-4d7f-b93c-b783ac3a43bc.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 26 of 48 · 945 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bestmade Natural Products Bio2KALI PHOS, MAG PHOS, NAT MUR, NAT SULFBestmade Natural Productse9fc4f2f-a699-163f-e053-2995a90ab1fe2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio4CALC FLUOR, KALI MUR, NAT MUR, SILICEABestmade Natural Productsea224687-106e-3821-e053-2995a90aa69c2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio5FERR PHOS, KALI MUR, NAT MUR, KALI SULPHBestmade Natural Productsea22e5e7-491a-91ac-e053-2a95a90a44142025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio6FERR PHOS, KALI MUR, MAG PHOS, NAT MUR, NAT SULPHBestmade Natural Productsea233792-038f-39e7-e053-2995a90a20ad2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio11FERR PHOS, KALI MUR, KALI SULF, NAT MUR, NAT SULFBestmade Natural Productseaa202d7-4297-57ba-e053-2995a90a02952025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio12FERR PHOS, NAT MUR, KALI PHOS, MAG PHOSBestmade Natural Productseab251db-c69a-572d-e053-2a95a90ab3a02025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio13CALC PHOS, KALI SULF, KALI PHOS, NAT MURBestmade Natural Productseab2e339-c9e9-3048-e053-2995a90ae1492025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MURBestmade Natural Productseac26053-7c65-7c56-e053-2995a90a8e642025-01-22WarningsExact identifier
unii: 451W47IQ8X
Bestmade Natural Products Bio20CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULFBestmade Natural Productseb3b0d9d-5f1c-8a3b-e053-2a95a90a0e1f2025-01-22WarningsExact identifier
unii: 451W47IQ8X
Anise PyriteANISE PYRITEUriel Pharmacy Inc.a03cdeb0-8347-40cc-8d17-5510d99575c72025-01-22WarningsExact identifier
unii: C151H8M554
Bestmade Natural Products Bio27MAG PHOS, CALC PHOS, KALI PHOS, CALC FLUORBestmade Natural Productseb420652-ec68-6b46-e053-2995a90af98c2025-01-22WarningsExact identifier
unii: 451W47IQ8X
PTS/Stress RemedyACONITUM NAPELLUS, AMBRA GRISEA, ARGEMONE MEXICANA, ARNICA MONTANA, ARSENICUM ALBUM, BUTHUS AUSTRALIS, CACAO, CALCAREA CARBONICA, CEREBRUM SUIS, CICUTA VIROSA, GLANDULA SUPRARENALIS SUIS, HYOSCYAMUS NIGER, IGNATIA AMARA, KALI PHOSPHORICUM, LILIUM TIGRINUM, LITHIUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, STRAMONIUM, TARENTULA HISPANADeseret Biologicals, Inc.61111d6e-2480-4e89-bb0e-d712f044bdc72025-01-20WarningsExact identifier
unii: 451W47IQ8X
MetoxALLIUM SATIVUM, ARSENICUM ALBUM, ASCORBICUM ACIDUM, BERBERIS VULGARIS, BORON, CARBOLICUM ACIDUM, CYSTEINUM, FORMALINUM, GLYCYRRHIZA GLABRA, LANTHANUM METALLICUM, LAPPA MAJOR, L-METHIONINE, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NIOBIUM METALLICUM, NUX VOMICA, PHYTOLACCA DECANDRA, PLUMBUM METALLICUM, STILLINGIA SYLVATICA, TANTALUM METALLICUM, THYROIDINUM (SUIS), TRIFOLIUM PRATENSE, ALUMINIUM METALLICUM, ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, ARSENICUM ALBUM, AURUM METALLICUM,Deseret Biologicals, Inc.deeae030-c266-44ab-8bc7-32c3292c72472025-01-17WarningsExact identifier
unii: 451W47IQ8X
unii: AE28F7PNPL
Sodium Chloride Hypertonicity Ophthalmic Solution, 5%SODIUM CHLORIDE HYPERTONICITY OPHTHALMIC SOLUTION, 5%Reliable 1 Laboritories LLC29175c17-223e-5e92-e063-6294a90a71d22025-01-15WarningsExact identifier
unii: 451W47IQ8X
D-43ARSENIC TRIOXIDE, ATROPA BELLADONNA, BRYONIA ALBA ROOT, ACTIVATED CHARCOAL, BOS TAURUS PITUITARY GLAND, POSTERIOR, SODIUM SULFATE, VERATRUM ALBUM ROOT, ERIODICTYON CALIFORNICUM LEAF, SODIUM CHLORIDE, AND DIBASIC POTASSIUM PHOSPHATEDNA Labs, Inc.937e2b7e-4001-402f-bd12-dcff4627e9282025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-78HYPERICUM PERFORATUM, LACHESIS MUTA VENOM, LYTTA VESICATORIA, ECHINACEA ANGUSTIFOLIA, SODIUM CHLORIDE, AND PLANTAGO MAJORDNA Labs, Inc.d62673a9-8a67-4580-a8bf-25f85960a5552025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-86ARNICA MONTANA, SILICON DIOXIDE, SODIUM CHLORIDE, LEAD ACETATE ANHYDROUS, SELENICEREUS GRANDIFLORUS STEM, TRIBASIC CALCIUM PHOSPHATE, AND POTASSIUM IODIDEDNA Labs, Inc.54fa62d3-c129-4826-a794-f3dcc6b855bf2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-98STRYCHNOS NUX-VOMICA SEED, MATRICARIA CHAMOMILLA, ANEMONE PRATENSIS, SODIUM CHLORIDE, CALCIUM SULFIDE, GOLD, DAPHNE MEZEREUM BARK, PLATINUM, AND BERBERIS VULGARIS ROOT BARKDNA Labs, Inc.9b39b277-9eb2-44c9-9c0c-a8680a50e18d2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-129SODIUM CHLORIDEDNA Labs, Inc.ef130f08-1c34-4774-9298-2d1997e631fc2025-01-13WarningsExact identifier
unii: 451W47IQ8X
D-50HORSE CHESTNUT, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHYTOLACCA AMERICANA ROOT, AND STRONTIUM CARBONATEDNA Labs, Inc.df118b9b-dee7-4555-bcae-751007c1fd2c2025-01-13WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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