NDC 0944-4263 - ADYNOVATE

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
0944-4263
Package NDCs from labels
0944-4263-01
Manufacturer
Takeda Pharmaceuticals Amercia, Inc. | BAXALTA US INC. | Siegfried Hameln GmbH | Takeda Manufacturing Austria AG | Baxalta Belgium Manufacturing SA | Baxalta Manufacturing Sàrl | Takeda Manufacturing Singapore Pte. Ltd.
Effective date
2026-05-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ADYNOVATETakeda Pharmaceuticals Amercia, Inc. | BAXALTA US INC. | Siegfried Hameln GmbH | Takeda Manufacturing Austria AG | Baxalta Belgium Manufacturing SA | Baxalta Manufacturing Sàrl | Takeda Manufacturing Singapore Pte. Ltd.2026-05-28PLASMA DERIVATIVE
ADYNOVATE - BAXALTA US INC. | Baxalta Belgium Manufacturing SA | Siegfried Hameln GmbHBAXALTA US INC. | Baxalta Belgium Manufacturing SA | Siegfried Hameln GmbH2018-06-26PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-4263-01ADYNOVATE5 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,5 mL3000 [iU] in 5mL23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-4263ADYNOVATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT) PEGYLATED) KIT [TAKEDA PHARMACEUTICALS AMERCIA, INC.]22Unmatched20250331_ef290433-997f-4e98-86d6-42f6a99d6d18.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 21 of 55 · 1,094 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WalgreensSODIUM CHLORIDEWalgreen Company21dfc2cf-65ae-c3fb-e063-6294a90a0a942025-10-17Exact identifier
unii: 451W47IQ8X
Homeopathic Tea Tree Oil LiceEUCALYPTUS GLOBULUS, NATRUM MURIATICUMDOLGENCORP, LLC0a0c2db2-7eeb-909c-e063-6394a90a7a902025-10-15WarningsExact identifier
unii: 451W47IQ8X
Saline AmpoulesSODIUM CHLORIDE 0.9%Trifecta Pharmaceuticals USA, LLC.ee18ef7c-bb5d-30ec-e053-2a95a90a964e2025-10-13WarningsExact identifier
unii: 451W47IQ8X
Aminosyn-PFISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, ALANINE, ARGININE, ASPARTIC ACID, GLUTAMIC ACID, GLYCINE, HISTIDINE, PROLINE, SERINE, TAURINE, AND TYROSINEICU Medical Inc.46e74ce4-cd7e-437f-bf54-ca9b98eb26632025-10-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
EQUATE SALINE PACKETSNASAL CLEANING SALTWALMART INC9e905ecb-d4d5-514a-e053-2a95a90adfbb2025-10-08WarningsExact identifier
unii: 451W47IQ8X
EQUATE NETI POT SINUS WASHNASAL WASHWALMART INC9e90c1c1-4dcd-106e-e053-2995a90afd152025-10-08WarningsExact identifier
unii: 451W47IQ8X
GURUNANDA NASAL SALINENASAL WASHGURUNANDA LLC2b4d78ae-b587-6dfe-e063-6394a90a88762025-10-08WarningsExact identifier
unii: 451W47IQ8X
Sodium chlorideSODIUM CHLORIDEBecton Dickinson and Companyca3355f2-2cf0-4f58-bed5-0c4c0a7d35112025-10-08Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Homeopathic Calm DropsARSENIC TRIOXIDE 30C, MATRICARIA CHAMOMILLA12X, ARABICA COFFEE BEAN 30X, POTASSIUM CARBONATE30C, STRYCHNOS IGNATII SEED30X, LACHESIS MUTA VENOM12X, PHOSPHORIC ACID 3X, ANEMONE PULSATILLA 12C, VALERIAN 30C, ACONITUM NAPELLUS 6X, CHLORIDE ION 12X, STRYCHNOS NUX-VOMICA SEED 30CHISTORICAL REMEDIES LLP.69c35bc2-b9a0-4bb4-a56d-0e2d1c3f79582025-10-07WarningsExact identifier
unii: 451W47IQ8X
Homeopathic Moon dropsARSENIC CATION 30X, MATRICARIA CHAMOMILLA 6X, ARABICA COFFEE BEAN 12X, GELSEMIUM SEMPERVIRENS ROOT 12X, STRYCHNOS IGNATII SEED 30X, LYCOPODIUM CLAVATUM SPORE 30X, SODIUM CHLORIDE 30X, STRYCHNOS NUX VOMICA SEED 30X, VALERIAN 12C,Historical Remedies LLP0e7972a5-a930-4a52-8896-02ce810fa90b2025-10-07WarningsExact identifier
unii: 451W47IQ8X
Tri-Relief AntifungalSODIUM CHLORIDE, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGForces of Nature6fe97b54-8aa3-4d86-9055-0629589a416b2025-10-06WarningsExact identifier
unii: 451W47IQ8X
Bone LiquescenceTARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, CALCAREA MURIATICA, EQUISETUM ARVENSE, JUGLANS NIGRA, SESAME OIL, CALCAREA SULPHURICA, HEPAR (BOVINE), KIDNEY (BOVINE), MEDULLA OSSIS SUIS, MENADIONE, THYROIDINUM (BOVINE), VITAMIN A, VITAMIN D3, CALCAREA PHOSPHORICA, CALCAREA CARBONICA, CALCAREA FLUORICA, MANGANUM METALLICUM, NICCOLUM METALLICUM, MAGNESIUM METALLICUMNutritional Specialties, Inc.28c244ca-7a99-4750-9942-32fdf4d3dac92025-10-06WarningsExact identifier
unii: M4I0D6VV5M
VirexADENOVIREN NOSODE, ASCLEPIAS TUBEROSA, CALCAREA ARSENICICA, CAMPHORA, COXSACKIE A2 NOSODE, COXSACKIE A3 NOSODE, COXSACKIE A4 NOSODE, COXSACKIE A5 NOSODE, COXSACKIE A7 NOSODE, COXSACKIE B1 NOSODE, COXSACKIE B3 NOSODE, COXSACKIE B4 NOSODE, COXSACKIE B5 NOSODE, CYTOMEGALOVIRUS NOSODE, ECHINACEA PURPUREA, EPSTEIN-BARR VIRUS NOSODE, EUPHRASIA OFFICINALIS, INFLUENZINUM, LAC VACCINUM, MORBILLINUM, NATRUM MURIATICUM, PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, TRIFOLIUM PRATENSE, VARIOLINUMNutritional Specialties, Inc.4baa5c95-79a6-4ae8-a8c4-1edbf308f92c2025-10-03WarningsExact identifier
unii: 451W47IQ8X
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Jet LagECHINACEA, ALUMINA, ARALIA QUINQUEFOLIA, ARGENTUM, ARNICA MONTANA, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BRYONIA, CANTHARIS, CHELIDONIUM MAJUS, CONIUM MACULATUM, GELSEMIUM SEMPERVIRENS, IODIUM, KALI CARBONICUM, KALI IODATUM, LYCOPODIUM CLAVATUM, LYCOPUS VIRGINICUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOXICODENDRON, SABAL SERRULATA, THYROIDINUM.Newton Laboratories, Inc.9c21c935-4ebc-1efd-e053-2995a90aa1562025-09-18WarningsExact identifier
unii: 451W47IQ8X
Calcium ChlorideCALCIUM CHLORIDEProPharma Distribution3eef0115-26f6-2abe-e063-6294a90aa2892025-09-16Adverse reactionsExact identifier
unii: M4I0D6VV5M
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
unii: M4I0D6VV5M
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: 4QD397987E
unii: M4I0D6VV5M

Reported adverse events (FAERS/openFDA)#

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