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 39 of 55 · 1,094 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERHikma Pharmaceuticals USA Inc.78ef7ad3-451d-43d0-a9b6-5cf0aadca0032024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEHikma Pharmaceuticals USA Inc.e5ee8caa-b6ca-45ba-98fb-8305e62821412024-04-10Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERB. Braun Medical Inc.8fc8d87a-3951-4ac5-97df-c161ffc904752024-04-10Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hers PlusCALENDULA OFFICINALIS, SAMBUCUS NIGRA, ALLIUM SATIVUM, CLEMATIS ERECTA, DULCAMARA, SARSAPARILLA (SMILAX REGELII), GRAPHITES, PETROLEUM, ARSENICUM ALBUM, CROTON TIGLIUM, MERCURIUS SULPHURATUS RUBER, NATRUM MURIATICUM, NITRICUM ACIDUM, RHUS TOX, SEPIA, THUJA OCCIDENTALISDeseret Biologicals,Inc.e4636b80-f6c8-459c-8d0e-ff7801358b102024-04-09WarningsExact identifier
unii: 451W47IQ8X
Dextrose And Sodium ChlorideDEXTROSE AND SODIUM CHLORIDEB. Braun Medical Inc.8e6569ce-9714-497f-a94b-c6975c1d76f62024-04-02Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
SINU HCPLANTAGO MAJOR, PULSATILLA (PRATENSIS), LUFFA OPERCULATA, MERCURIUS IODATUS RUBER, MUCOSA NASALIS SUIS, EUPHORBIUM OFFICINARUM, ARGENTUM NITRICUM, HEPAR SULPHURIS CALCAREUM, CALCAREA CARBONICA, NATRUM MURIATICUM, SINUSITISINUMDeseret Biologicals, Inc.8b63e066-dd1b-4aee-a17b-4edc6b71a1cc2024-04-02WarningsExact identifier
unii: 451W47IQ8X
Eye WashWATERM-star (Hubei) Health&Care Products Co., Ltd.71706039-e250-4f08-9687-71b2928c4e462024-04-01WarningsExact identifier
unii: 059QF0KO0R
CVS Health Sterile Saline MistSODIUM CHLORIDECVS Pharmacy14931004-1efb-e331-e063-6294a90ad66e2024-03-26WarningsExact identifier
unii: 451W47IQ8X
Aqua marinaSODIUM CHLORIDEBoiron14945760-30b5-27d3-e063-6394a90a8a322024-03-26Exact identifier
unii: 451W47IQ8X
Headache HPBELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUMEnergique, Inc.5dca8670-c931-47e3-af89-b5f09f5f4e022024-03-26WarningsExact identifier
unii: 451W47IQ8X
Calcium ChlorideCALCIUM CHLORIDEAmerican Regent, Inc.c5ef90b3-6ef0-410c-97d7-66a130b907412024-03-26Warnings, Adverse reactionsExact identifier
unii: M4I0D6VV5M
Potassium Chloride in Dextrose and Sodium ChlorideDEXTROSE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDEB. Braun Medical Inc.59ccc717-c374-41c0-be58-9647df8811602024-03-26Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
V-Fem CareAGARICUS MUSC., ARSENICUM ALB., AUR. MET., BERBER. AQUI., CALADIUM SEGUINUM, CANDIDA ALBICANS, CANTHARIS, CONIUM, GRAPHITES, HELONIAS DIOICA, HYDRASTIS, KALI CARB., KREOSOTUM, LYCOPODIUM, MERC. VIV., MUREX PURPUREA, NAT. MUR., NITRICUM AC., PULSATILLA, RHUS TOXICODENDRON, SEPIA, SULPHUR, TARENTULA HISPANA, THUJA OCC., ZINC. MET., APIS MEL., HAMAMELISNewton Laboratories, Inc.14800c19-e5c6-924b-e063-6394a90a15e52024-03-25WarningsExact identifier
unii: 451W47IQ8X
ControlANACARDIUM ORIENTALE, AQUA MARINA, ARGENTUM NITRICUM, ASARUM CANADENSE, BLATTA ORIENTALIS, BUFO RANA, CEREBRUM SUIS, CLEMATIS ERECTA, CUPRUM ACETICUM, HYPOTHALAMUS SUIS, IGNATIA AMARA, KALI PHOSPHORICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, NATRUM SULPHURICUM, PLACENTA TOTALIS SUIS, RHUS TOX, THUJA OCCIDENTALIS, THYMOLUM, VALERIANA OFFICINALISDeseret Biologicals, Inc.9daec04d-44fb-4d0f-8e21-1109f515eb5d2024-03-25WarningsExact identifier
unii: 451W47IQ8X
GriefCIMICIFUGA RACEMOSA, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, SEPIA, CEREBRUM SUIS, IGNATIA AMARA, NATRUM MURIATICUM, AMBRA GRISEA, DNA, AURUM METALLICUM, COCCULUS INDICUS, DIGITALIS PURPUREA, HELLEBORUS NIGER, LYCOPODIUM CLAVATUM, STAPHYSAGRIADeseret Biologicals, Inc.e7ff1297-512e-4e95-a918-1c57fa3a50dd2024-03-25WarningsExact identifier
unii: 451W47IQ8X
ULINE EyewashEYEWASHUline.14545fc9-1fb4-befa-e063-6294a90a04742024-03-23WarningsExact identifier
unii: 059QF0KO0R
Bladder Kidney Meridian OpenerAPIS MELLIFICA, ARGENTUM NITRICUM, BERBERIS VULGARIS, CANTHARIS, EQUISETUM ARVENSE, KALI BICHROMICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PHOSPHORUS, RHUS TOX, SEPIA, TEREBINTHINA, THUJA OCCIDENTALISDeseret Biologicals, Inc.08e96657-9b15-41e3-88e5-8915cefb43be2024-03-15WarningsExact identifier
unii: 451W47IQ8X
BreatheARGENTUM NITRICUM, NATRUM MURIATICUM, SULPHUR, ACONITUM NAPELLUS, ARSENICUM ALBUM, RHUS TOX, ADENOSINUM CYCLOPHOSPHORICUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, LUNG (SUIS), MUCOSA NASALIS SUIS, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, ACETYLCHOLINE CHLORIDE, COUMARINUM, MALVIN, DYSENTERY BACILLUS, PROTEUS (MORGANI)Deseret Biologicals, Inc8dbdd623-a486-4cf8-acdb-ad051dc743482024-03-15WarningsExact identifier
unii: 451W47IQ8X
Balanced SaltSODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATEB. Braun Medical Inc.74ab8883-0a5f-46b4-8998-9358f6fd4ef42024-03-13Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
unii: M4I0D6VV5M
ElevateLYCOPODIUM CLAVATUM, NATRUM MURIATICUM, SEPIA, CAUSTICUM, PHOSPHORUS, SULPHUR, 5-HYDROXYTRYPTOPHAN, ALUMINA, SILICEA, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, NOREPINEPHRINE (BITARTRATE), PHENYLETHYLAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), ADENOSINUM CYCLOPHOSPHORICUM, CEREBRUM (SUIS), DIENCEPHALON (SUIS), FUNICULUS UMBILICALIS SUIS, PANTOTHENIC ACID, PINEAL GLAND (SUIS), SARCOLACTICUM ACIDUM, FAECALIS (ALKALIGENES), GAERTNER BACILLUS (BACH), PROTEUS (VULGARIS)Deseret Biologicals, Inc.5c0ff0d8-2db4-42c0-9b6d-572f9ad0c98b2024-03-11WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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