FDA.reportPublic FDA data

NDC 0944-4622-03 - 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
0944-4622
Requested NDC
0944-4622-03
Package NDCs from labels
0944-4622-03, 0944-4622-02, 0944-4622-01
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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2020-03-05These highlights do not include all the information needed to use ADYNOVATE ® safely and effectively. See full prescribing information for ADYNOVATE. ADYNOVATE, (Antihemophilic Factor, Recombinant, PEGylated) Lyophilized Powder for Solution For Intravenous Injection Initial U.S. Approval: 2015
2020-03-05These highlights do not include all the information needed to use ADYNOVATE ® safely and effectively. See full prescribing information for ADYNOVATE. ADYNOVATE, (Antihemophilic Factor, Recombinant, PEGylated) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 2015
2020-03-05These highlights do not include all the information needed to use ADYNOVATE ® safely and effectively. See full prescribing information for ADYNOVATE. ADYNOVATE, (Antihemophilic Factor, Recombinant, PEGylated) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 2015
2020-01-31These highlights do not include all the information needed to use ADYNOVATE ® safely and effectively. See full prescribing information for ADYNOVATE. ADYNOVATE, (Antihemophilic Factor, Recombinant, PEGylated) Lyophilized Powder for Solution For Intravenous Injection Initial U.S. Approval: 2015
2020-01-31These highlights do not include all the information needed to use ADYNOVATE ® safely and effectively. See full prescribing information for ADYNOVATE. ADYNOVATE, (Antihemophilic Factor, Recombinant, PEGylated) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 2015
2020-01-31These highlights do not include all the information needed to use ADYNOVATE ® safely and effectively. See full prescribing information for ADYNOVATE. ADYNOVATE, (Antihemophilic Factor, Recombinant, PEGylated) Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-4137-01ADYNOVATE5 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,5 mL250 [iU] in 2mL23
0944-4622-01ADYNOVATE1 in 1 CARTONKIT123
0944-4622-02ADYNOVATE1 in 1 KITKIT123
0944-4622-03ADYNOVATE1 in 1 CONTAINERKIT123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-4622ADYNOVATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT) PEGYLATED) KIT [TAKEDA PHARMACEUTICALS AMERCIA, INC.]22Current NDC, Legacy NDC, 4 package rows20250331_ef290433-997f-4e98-86d6-42f6a99d6d18.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0944-4622-01EA - Each0944-462240cddd83-05c8-4e30-9d54-53328e7b8cbd12016-11-08
0944-4622-02EA - Each0944-46222eea9184-d0c7-46da-acd7-5a56252969c812018-12-13
0944-4622-03EA - Each0944-46221d5796a2-6e99-4739-bff5-e5c09eaed18f12022-06-06

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 8 of 55 · 1,094 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM HYPOCHLOROUS, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.ad6a08ec-5eba-405b-8a07-79ac86ab3e7a2026-03-31WarningsExact identifier
unii: 451W47IQ8X
ANX HPARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUMBioActive Nutritional, Inc.96035891-aea3-4138-bb26-801ad819f6392026-03-30WarningsExact identifier
unii: 451W47IQ8X
Spleen LiquescenceQUERCUS ROBUR, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.d800456d-60f0-413d-b310-91b8b881f6b92026-03-30WarningsExact identifier
unii: 451W47IQ8X
DepressoforcePICRICUM ACIDUM, ARSENICUM ALBUM, AURUM METALLICUM, IGNATIA AMARA, NATRUM MURIATICUM, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.e6b98979-a38c-4f13-af03-f5ffa962b4fa2026-03-27WarningsExact identifier
unii: 451W47IQ8X
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.077a9171-283d-47b6-bddc-34c739f6d69d2026-03-27WarningsExact identifier
unii: 451W47IQ8X
Buffer pHCHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIANaturalCare2161a2e2-613d-4dac-a5f6-796d40e849d92026-03-25WarningsExact identifier
unii: 451W47IQ8X
Reflux AwayABIES NIGRA, ANTIMONIUM CRUDUM, ARGENTUM NITRICUM, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLOCYNTHIS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICANaturalCare8a00a72f-60df-4477-b7b8-abb6355e34da2026-03-24WarningsExact identifier
unii: 451W47IQ8X
Worafy Gentle Eye WashSODIUM CHLORIDEShenzhen Shandian Jingling Technology Co., Ltd.4da864dc-e10c-1db9-e063-6394a90a09842026-03-22WarningsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDE HYPERTONICITYSODIUM CHLORIDEYYBA CORP439653b9-99b8-4799-8d67-4a2ada9c67832026-03-20WarningsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Altachlore Sodium Chloride Hypertonicity Ophthalmic 5 PercentSODIUM CHLORIDEAltaire Pharmaceuticals Inc.e13fd053-9420-490c-a43e-e14b0930cb4e2026-03-18WarningsExact identifier
unii: 451W47IQ8X
UniversaltoxALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, HORDEUM VULGARE, NASTURTIUM AQUATICUM, RAPHANUS SATIVUS, TRITICUM AESTIVUM, IODIUM, UBIDECARENONUM, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, MANGANESE GLUCONATE, ORYZA SATIVA, THYROIDINUM (SUIS), CALCAREA CARBONICA, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RHUS TOX, CORTISONE ACETICUMBioActive Nutritional, Inc.ad454e8a-4f78-4aac-90d9-a3f26a6fbe422026-03-17WarningsExact identifier
unii: 451W47IQ8X
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
BM BIO27CALC PHOS, KALI PHOS, NAT MURBM Private Limited4d229815-05f4-27c5-e063-6394a90ac8652026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO1CALC PHOS, FERR PHOS, KALI PHOS, NAT MURBM Private Limited4d265d99-fdbb-5efb-e063-6394a90a89ac2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d26b4a9-ee27-6915-e063-6294a90a5d4d2026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO12FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.BM Private Limited4d2747ad-958e-63a1-e063-6294a90aea662026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b812c9-fb0a-5ee0-e063-6294a90a03e12026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b88e7c-eca0-5540-e063-6294a90a1b182026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDEVenture Healthcare Ltd31b8c3f4-e528-c69d-e063-6294a90a5a342026-03-16WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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