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 42 of 48 · 945 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sodium ChlorideSODIUM CHLORIDEFresenius Kabi USA, LLC51da05ce-e3c4-4ef5-a845-dc869152e17f2022-10-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.ebd0839e-2e1d-4e0e-986c-19f1f5c763582022-09-15WarningsExact identifier
unii: 6OZP39ZG8H
Dr Talbots Infant Daily Allergy ReliefALLIUM CEPA 12X,ARALIA RACEMOSA 12X,EUPHRASIA OFFICINALIS 12X,GALPHIMIA GLAUCA 12X,HISTAMINUM HYDROCHLORICUM 12X,LUFFA OPERCULATA 12X,PULSATILLA 12X,SOLIDAGO 12X,NATRUM MURIATICUM 6XTalbot's Pharmaceuticals Family Products,LLC.e8bdcc8a-c947-ff5d-e053-2a95a90a3b922022-09-12WarningsExact identifier
unii: 451W47IQ8X
REFRESH OPTIVE AdvancedCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, AND POLYSORBATE 80Allergan, Inc.aaa943e4-7c38-4c5a-b7c0-5a656d8cafc02022-09-01WarningsExact identifier
unii: 6OZP39ZG8H
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLC6a1322c7-7767-4569-aa22-9d2e363312832022-08-30WarningsExact identifier
unii: 451W47IQ8X
Kids Cold and Cough Nighttime Grape FlavorONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFURHyland's Consumer Health Inc.e676dbb7-212f-47e3-e053-2995a90af4e12022-08-17WarningsExact identifier
unii: 451W47IQ8X
Kids Cold and Cough Daytime Grape FlavorONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFURHyland's Consumer Health Inc.e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d2022-08-16WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Kids Mist PediaMedsSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.e5c5b580-1d9f-3081-e053-2995a90a80312022-08-08WarningsExact identifier
unii: 451W47IQ8X
Sterile Saline Kids Mist SinuCleanse BreatheSODIUM CHLORIDEASCENT CONSUMER PRODUCTS, INC.e5c5c313-046f-b0a7-e053-2a95a90a2a072022-08-08WarningsExact identifier
unii: 451W47IQ8X
Premasol - sulfite-free (Amino Acid)LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDEBaxter Healthcare Company9afdcc3e-0d06-47f4-86ca-40da48b2b02b2022-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
unii: AE28F7PNPL
SODIUM CHLORIDESODIUM CHLORIDEBaxter Healthcare Corporation123bd10a-90c7-499e-97f6-acf7e0f0fb4e2022-07-29Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCfad9615f-7004-415d-9f69-ee9ff95f00672022-07-12WarningsExact identifier
unii: 451W47IQ8X
BHI ConstipationDIOSCOREA VILLOSA TUBER, SODIUM CHLORIDE, AND STRYCHNOS NUX-VOMICA SEEDMediNatura Inc0365b75b-fee4-4c1d-89ab-c692bdd73f752022-07-07WarningsExact identifier
unii: 451W47IQ8X
Natrium Muriaticum 6XSODIUM CHLORIDESeroyal USA0ebf18de-12fe-0bc4-e054-00144ff88e882022-07-07WarningsExact identifier
unii: 451W47IQ8X
REFRESH Optive Mega-3CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80Allergan, Inc.c5f2b3f2-2071-45bd-a010-67f848bc02332022-06-30WarningsExact identifier
unii: 6OZP39ZG8H
ErogetoneARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIAEnergique, Inc.1e872ecd-e7a5-463d-9832-47b7046096db2022-06-28WarningsExact identifier
unii: 451W47IQ8X
Cardioplegic SolutionPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEFresenius Kabi, USA, LLCeb360dc4-88d6-4b28-9b61-bc359e16bd222022-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
Calcarea MuriaticaCALCAREA MURIATICAHahnemann Laboratories, INC.df517477-164b-33cc-e053-2a95a90a20832022-05-18Exact identifier
unii: M4I0D6VV5M
Sodium ChlorideSODIUM CHLORIDEB. Braun Medical Inc.24a08a93-df23-474b-873e-c59ec8855f9f2022-03-14Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Wild Horse 777 Moisturizing NasalSODIUM CHLORIDEWild Horse 777, Inc.b0b4dadd-11fa-3dbb-e053-2995a90a20972022-03-14WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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