FDA.reportPublic FDA data

NDC 0944-2803 - Aralast NP

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
0944-2803
Package NDCs from labels
0944-2803-03
Manufacturer
Takeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbH
Effective date
2025-11-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Aralast NP - Takeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbHTakeda Pharmaceuticals America, Inc. | Takeda Manufacturing Austria AG | Siegfried Hameln GmbH2025-11-25PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-2803-03AralastNP25 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,25 mL16 mg in 1mL20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-2803ARALAST NP (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]18Unmatched20241121_a9a5b46e-04da-41bd-bb5f-c4936b664fef.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
.ALPHA.1-PROTEINASE INHIBITOR HUMANACTIVE INGREDIENTF43I396OISARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4
.ALPHA.1-PROTEINASE INHIBITOR HUMANACTIVE MOIETYF43I396OISARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4
ALBUMIN HUMANINACTIVE INGREDIENTZIF514RVZRARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4
TRI-N-BUTYL PHOSPHATEINACTIVE INGREDIENT95UAS8YAF5ARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4
ZINCINACTIVE INGREDIENTJ41CSQ7QDSARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]4

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 11 of 67 · 1,326 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RESP EASESODIUM CHLORIDELaboratoire Unither31b7eb13-39c3-6f0e-e063-6394a90a40112026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b8bb9c-d30f-152f-e063-6394a90a52082026-03-16WarningsExact identifier
unii: 451W47IQ8X
RESP EASESODIUM CHLORIDELaboratoire Unither31b8dcbd-9e6b-1edc-e063-6394a90aac732026-03-16WarningsExact identifier
unii: 451W47IQ8X
BM BIO20CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULFBM Private Limited4d285396-9df8-86bc-e063-6294a90ad4de2026-03-16WarningsExact identifier
unii: 451W47IQ8X
HZ HPLYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NITRICUM ACIDUM, RANUNCULUS BULBOSUS, RHUS TOX, SEPIA, THUJA OCCIDENTALISBioActive Nutritional, Inc.b662dea8-4eb5-4c80-a5ab-7d36887327732026-03-13WarningsExact identifier
unii: 451W47IQ8X
Drop20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Pick Enterprises Corpbaa96813-dc95-472e-a834-880a0cd484a72026-03-13WarningsExact identifier
unii: 451W47IQ8X
Appetrol 20FUCUS VESICULOSUS, CHELIDONIUM MAJUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, QUERCUS GLANDIUM SPIRITUS, QUERCUS ROBUR, NUX VOMICA, PHYTOLACCA DECANDRA, ORNITHOGALUM UMBELLATUM, AGNUS CASTUS, BERBERIS AQUIFOLIUM, BERBERIS VULGARIS, SACCHARUM OFFICINALE, SOLIDAGO VIRGAUREA, CALCAREA CARBONICA, CARBO VEGETABILIS, MAGNESIA PHOSPHORICA, NATRUM PHOSPHORICUM, SINAPIS ARVENSIS, FLOS, UBIDECARENONUM, GRAPHITES, HYPOPHYSIS SUIS, PLACENTA TOTALIS SUIS, HYPOTHALAMUS (BOVINE)Carbalor LLCd66234a3-2477-42be-8f7b-283e3a5f87ed2026-03-12WarningsExact identifier
unii: 451W47IQ8X
VARICO HPCALCAREA FLUORICA, CARBO VEGETABILIS, HAMAMELIS VIRGINIANA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, PULSATILLA (VULGARIS), SECALE CORNUTUM, STAPHYSAGRIA, ZINCUM METALLICUMBioActive Nutritional, Inc.4d5354a8-52cf-4ad9-b5f7-f9207b0a5cd42026-03-11WarningsExact identifier
unii: J41CSQ7QDS
Restless Leg Symptom ReliefARSENICUM ALBUM, BUFO RANA, CAUSTICUM, CHAMOMILLA, CROTALUS HORRIDUS, DIGITALIS PURPUREA, LACHESIS MUTUS, LILIUM TIGRINUM, PULSATILLA, RHUS TOX, SULPHUR, TARENTULA HISPANA, VISCUM ALBUM AND ZINCUM METALLICUM.King Bio Inc.07ab09eb-9430-4ea2-90c0-db2ca237cc962026-03-10WarningsExact identifier
unii: J41CSQ7QDS
Constitutional EnhancerACONITUM NAPELLUS, ARSENICUM ALBUM, BARYTA CARBONICA, BRYONIA, CALCAREA CARBONICA, CANTHARIS, GELSEMIUM SEMPERVIRENS, GRAPHITES, HYDRASTIS CANADENSIS, KALI IODATUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, MERCURIUS VIVUS, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHUS TOX, SEPIA, SILICEA AND SULPHUR.King Bio Inc.448becd7-58aa-40ae-9b4b-39f48a8f13dd2026-03-10WarningsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.018a8807-1331-41c3-4889-c7ec502a90432026-03-09Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
foster and thrive clearlaxPOLYETHYLENE GLYCOL 3350Strategic Sourcing Services LLC684e35cc-5a4f-458d-b5e7-e1933fea11392026-03-07WarningsExact identifier
unii: G2M7P15E5P
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Headache and Migraine ReliefBELLADONNA, BRYONIA, CAPSICUM ANNUUM, GELSEMIUM, GLONOINUM, IGNATIA AMARA, KALI BICHROMICUM, KALI CARBONICUM, LYCOPODIUM, NATRUM MURIATICUM, NICCOLUM METALLICUM, NUX VOMICA, SANGUINARIA, SECALE CORNUTUM, SPIGELIA ANTH AND SULPHUR.King Bio Inc.efbfd58c-f3a6-4734-a37f-9f58fded990a2026-03-06WarningsExact identifier
unii: 451W47IQ8X
Snore ControlBROMIUM, CHAMOMILLA, CINCHONA, CUPRUM METALLICUM, HELLEBORUS NIGER, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, LAUROCERASUS, NUX VOMICA, PHOSPHORICUM ACIDUM, RHUS TOX, SILICEA, STRAMONIUM, SULPHUR AND ZINCUM METALLICUM.King Bio Inc.704bb574-6c54-49d1-bdae-81ffe0e79d102026-03-04WarningsExact identifier
unii: J41CSQ7QDS
Grain and WheatADRENALINUM, AVENA SATIVA, BRYONIA (ALBA), GLYCINE MAX (SOY), HISTAMINUM HYDROCHLORICUM, BARLEY, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PULSATILLA (PRATENSIS), RYE, WHEAT, CORNNaturalCare3bd8e473-9aac-4a0c-9117-1f1488a75b7b2026-03-03WarningsExact identifier
unii: 451W47IQ8X
Thyroid SupportCALCAREA CARBONICA, CALCAREA IODATA, CAUSTICUM, FERRUM IODATUM, FUCUS VESICULOSUS, KALI IODATUM, NATRUM MURIATICUM, THYROIDINUM (BOVINE)NaturalCare75648609-288c-4988-8b96-46f52d639bd32026-03-03WarningsExact identifier
unii: 451W47IQ8X
Arthritis Pain and Joint ReliefACTAEA SPICATA, AESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA, CALCAREA CARBONICA, CALCAREA FLUORICA, CAUSTICUM, CIMICIFUGA RACEMOSA, FORMICUM ACIDUM, HYPERICUM PERFORATUM, LEDUM PALUSTRE, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, RHODODENDRON CHRYSANTHUM, RHUS TOX, RUTA GRAVEOLENS, SALICYLICUM ACIDUM, SEPIA AND ZINCUM METALLICUM.King Bio Inc.8ecb7378-ea84-483c-ba1c-852d1ae7b90d2026-03-02WarningsExact identifier
unii: J41CSQ7QDS
Back, Muscle and Joint ReliefAESCULUS HIPPOCASTANUM, ARNICA MONTANA, BELLIS PERENNIS, BRYONIA, CALCAREA CARBONICA, CALCAREA FLUORICA, CIMICIFUGA RACEMOSA, COBALTUM METALLICUM, GNAPHALIUM POLYCEPHALUM, HYPERICUM PERFORATUM, KALI CARBONICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, RUTA GRAVEOLENS, AND ZINCUM METALLICUM.King Bio Inc.c6e50f93-bc45-4755-8ab0-dbe0d9987fca2026-03-02WarningsExact identifier
unii: J41CSQ7QDS
Focus, Comprehension and LearningAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, CALCAREA CARBONICA, IGNATIA AMARA, LECITHIN, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, OLEANDER, PHOSPHORICUM ACIDUM, RNA AND ZINCUM METALLICUM.King Bio Inc.b2a4dd82-7dd4-4dff-8a03-770f524bce1f2026-03-02WarningsExact identifier
unii: J41CSQ7QDS

Reported adverse events (FAERS/openFDA)#

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