FDA.reportPublic FDA data

NDC 0169-8301 - 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
0169-8301
Package NDCs from labels
0169-8301-11, 0169-8301-90
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
0169-8301-11ESPEROCT4 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,4 mL750 [iU] in 1mL7
0169-8301-90ESPEROCT4 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,4 mL750 [iU] in 1mL7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0169-8301ESPEROCT (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 20 of 48 · 945 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEProPharma Distribution3868864f-4f46-d2a1-e063-6394a90a65d52025-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: C151H8M554
unii: 451W47IQ8X
HerpaOneGRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIGAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions6b196d97-6446-4651-97ef-6615cf3e31732025-07-11WarningsExact identifier
unii: 451W47IQ8X
POTASSIUM CHLORIDE IN SODIUM CHLORIDESODIUM CHLORIDE AND POTASSIUM CHLORIDEB. Braun Medical Inc.ecc38772-246a-46c4-b42a-b9b81124f27f2025-07-11Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Leader Sinus Wash Saline Refill PacketsSODIUM BICARBONATE, SODIUM CHLORIDECardinal Health, 110 dba LEADERfb192a6d-318e-4d2b-89b6-42ac023e4fbd2025-07-09WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.0d59a04a-32e6-485b-b638-a1e6c09e96422025-07-09Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Schuessler Tissue Salts Nat Mur Fluid Balance 9NATRUM MURIATICUMMartin & Pleasance Pty Ltd0b21c366-fff6-4754-a671-35481ec2c4bd2025-07-07WarningsExact identifier
unii: 451W47IQ8X
Normal SaltSODIUM CHLORIDETwin Med LLCdc82ff0f-8600-373a-e053-2995a90a75052025-07-03WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDEAdvanced Rx LLC40f471b7-27cf-4ad4-aef6-cc9d0623ddd92025-07-02WarningsExact identifier
unii: 451W47IQ8X
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLC0956bd7c-d46f-483a-bf2c-9e11c6111ebf2025-07-02Exact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
DIANEAL LOW CALCIUM WITH DEXTROSESODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE AND DEXTROSEVantive US Healthcare LLCb79ef556-37b3-4fd0-8589-c633033be9df2025-07-02Exact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
ParasodeARTEMISIA VULGARIS ROOT, CHELIDONIUM MAJUS WHOLE, PUNICA GRANATUM ROOT BARK, SPIGELIA ANTHELMIA WHOLE, KRAMERIA LAPPACEA ROOT, ARSENIC TRIOXIDE, IRON, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ARTEMISIA CINA PRE-FLOWERING TOP, SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS, GRAPHITE, CALOMEL, SODIUM CHLORIDE, AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEZorex0ed722dc-cd25-4a15-b3f8-052cc7bcd9ec2025-07-01WarningsExact identifier
unii: 451W47IQ8X
EXTRANEALICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEVantive US Healthcare LLCd5b85158-b0d6-4855-9d07-8d1b3ad9ab712025-06-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporation958d35f0-6834-43be-a700-fa58f38b4c192025-06-30Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Calcium ChlorideCALCIUM CHLORIDE INJECTIONMedefil, Inc.90b8936e-61f2-5318-e053-2995a90aac442025-06-17Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
HAIR STIMPEDICULUS CAPITIS, THYROIDINUM (SUIS), BARYTA CARBONICA, BORAX, CALCAREA CARBONICA, CINCHONA OFFICINALIS, GLANDULA SUPRARENALIS SUIS, HYDROFLUORICUM ACIDUM, MERCURIUS SOLUBILIS, MEZEREUM, NATRUM MURIATICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SEPIA, SILICEA, SULPHUR, THUJA OCCIDENTALIS, VINCA MINORThe Wellness Center for Research and Education, Inc.8ecc05ff-ed5a-4157-9100-1c7912686f072025-06-06WarningsExact identifier
unii: 451W47IQ8X
MBM 7 LungCOCCUS CACTI, LUNG (SUIS), IGNATIA AMARA, CAUSTICUM, NATRUM MURIATICUMThe Wellness Center for Research and Education, Inc.6eb49fb5-485c-4b48-b231-4db88ebe20df2025-06-04WarningsExact identifier
unii: 451W47IQ8X
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
IntimateANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA (HUMAN), GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.066bd402-378b-48aa-9515-188c261a3f4c2025-05-27WarningsExact identifier
unii: C151H8M554

Reported adverse events (FAERS/openFDA)#

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