NDC 0944-2804-04 - 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: 0944-2804
Requested NDC: 0944-2804-04
Package NDCs from labels: 0944-2804-04
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
Label	Manufacturer	Effective date	Type
Aralast NP - Takeda Pharmaceuticals America, Inc. \| Takeda Manufacturing Austria AG \| Siegfried Hameln GmbH	Takeda Pharmaceuticals America, Inc. \| Takeda Manufacturing Austria AG \| Siegfried Hameln GmbH	2025-11-25	PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0944-2804-04	AralastNP	50 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	50 mL	16 mg in 1mL	20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0944-2804	ARALAST NP (ALPHA-1-PROTEINASE INHIBITOR (HUMAN)) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	18	Unmatched	20241121_a9a5b46e-04da-41bd-bb5f-c4936b664fef.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
.ALPHA.1-PROTEINASE INHIBITOR HUMAN	ACTIVE INGREDIENT	F43I396OIS	ARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	4
.ALPHA.1-PROTEINASE INHIBITOR HUMAN	ACTIVE MOIETY	F43I396OIS	ARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	4
ALBUMIN HUMAN	INACTIVE INGREDIENT	ZIF514RVZR	ARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	4
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	ARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	ARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	4
TRI-N-BUTYL PHOSPHATE	INACTIVE INGREDIENT	95UAS8YAF5	ARALAST NP (ALPHA.1-PROTEINASE INHIBITOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	4
ZINC	INACTIVE INGREDIENT	J41CSQ7QDS	ARALAST 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 43 of 64 · 1,270 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aging Eye Formula	CINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, GERMANIUM METALLICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, NATRUM MURIATICUM	Nutritional Specialties, Inc.	4510fe59-cc28-4585-925f-42508a60abd0	2024-05-13	Warnings	Exact identifier unii: 451W47IQ8X unii: J41CSQ7QDS
Bio Glyoxal Phase	ARNICA MONTANA, BAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), SANGUINARIA CANADENSIS, EUPATORIUM PERFOLIATUM, EUPHORBIUM OFFICINARUM, DOPAMINE HYDROCHLORIDE, PHYTOLACCA DECANDRA, ACONITUM NAPELLUS, ARGENTUM NITRICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, MERCURIUS CORROSIVUS, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SULPHUR, THUJA OCCIDENTALIS, CORTISONE ACETICUM, ACETALDEHYDE, FORMALINUM, HEPAR SULPHURIS CALCAREUM, LACHESIS MUTUS, ZINCUM METALLICUM	Deseret Biologicals, Inc.	d43db203-7756-43a5-bd68-aa070d429f60	2024-05-09	Warnings	Exact identifier unii: J41CSQ7QDS
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	47a0313f-36df-4fa6-a828-c9e1946ba9b0	2024-05-08	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Varico HP	AESCULUS HIPPOCASTANUM, CALCAREA FLUORICA, CARBO VEGETABILIS, CARDUUS MARIANUS, HAMAMELIS VIRGINIANA, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, PAEONIA OFFICINALIS, PULSATILLA (PRATENSIS), SECALE CORNUTUM, SEPIA, STAPHYSAGRIA, ZINCUM METALLICUM	Energique, Inc.	83aff417-88f3-4c03-b5fc-9c0df265d3c3	2024-05-08	Warnings	Exact identifier unii: J41CSQ7QDS
Ear Ring	ALLIUM CEPA, ARGENTUM NITRICUM, CHENOPODIUM ANTHELMINTICUM, DULCAMARA, GINKGO BILOBA, CHININUM SULPHURICUM, CARTILAGO SUIS, MUCOSA NASALIS SUIS, ASARUM CANADENSE, ONOSMODIUM VIRGINIANUM, NATRUM SALICYLICUM, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, CYCLAMEN EUROPAEUM, GOSSYPIUM HERBACEUM, GRAPHITES, KREOSOTUM, PHOSPHORUS, PLUMBUM METALLICUM, THERIDION, ZINCUM METALLICUM	Deseret Biologicals, Inc.	43585c0d-50da-411d-9f26-c8c0325dd9d5	2024-05-08	Warnings	Exact identifier unii: J41CSQ7QDS
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	f0cc6713-4d47-49be-8116-901c99002b6b	2024-05-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	7f22c06b-6b4d-4b49-a4b2-d2169f2bd653	2024-05-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	Asclemed USA, Inc.	f4ca52c6-9f90-7bb5-e053-2a95a90ae3ff	2024-05-07	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	97001218-086c-430a-9e0d-6c7031c91d94	2024-05-06	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	fe5b5182-c859-4c74-b2e0-467be5b2e329	2024-05-06	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Neurotransmitter Pro	AETHUSA CYNAPIUM, GINKGO BILOBA, KALI PHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALUMINA, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CORTISONE ACETICUM, LEVOTHYROXINUM, LYCOPODIUM CLAVATUM, NADIDUM, PHOSPHORUS, UBIDECARENONUM, ZINCUM METALLICUM, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, GABA (GAMMA-AMINOBUTYRIC ACID), HISTAMINUM HYDROCHLORICUM, MELATONIN, NOREPINEPHRINE (BITARTRATE), OXYTOCIN, SEROTONIN (HYDROCHLORIDE)	Energique, Inc.	a80e5e2d-4c53-4b18-b89b-a7790073b7ed	2024-05-06	Warnings	Exact identifier unii: J41CSQ7QDS
Neurotransmitter Pro	AETHUSA CYNAPIUM, GINKGO BILOBA, KALI PHOSPHORICUM, CEREBRUM SUIS, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALUMINA, ANACARDIUM ORIENTALE, ARSENICUM ALBUM, CORTISONE ACETICUM, LEVOTHYROXINUM, LYCOPODIUM CLAVATUM, NADIDUM, PHOSPHORUS, UBIDECARENONUM, ZINCUM METALLICUM, ACETYLCHOLINE CHLORIDE, DOPAMINE HYDROCHLORIDE, GABA (GAMMA-AMINOBUTYRIC ACID), HISTAMINUM HYDROCHLORICUM, MELATONIN, NOREPINEPHRINE (BITARTRATE), SEROTONIN (HYDROCHLORIDE), OXYTOCIN	Energique, Inc.	b433c635-e38b-4b3a-89cb-4a72a386ad84	2024-05-06	Warnings	Exact identifier unii: J41CSQ7QDS
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	f2475fa3-ab1d-4b81-8127-b58cd0790a54	2024-05-06	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Weed Grass Antigens	ALLIUM CEPA, ARSENICUM ALBUM, NATRUM MURIATICUM, NUX VOMICA, PULSATILLA (PRATENSIS), ABROTANUM (ARTEMISIA ABROTANUM), ABSINTHIUM, AGRIMONIA EUPATORIA, FLOS, ALFALFA, AMBROSIA ARTEMISIAEFOLIA, ARUNDO MAURITANICA, BAMBUSA ARUNDINACEA, CICHORIUM INTYBUS, FLOS, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, RUMEX CRISPUS, SABADILLA, SINAPIS ARVENSIS, FLOS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, TRIFOLIUM REPENS,	Energique, Inc.	8a28f56a-6010-42e3-b360-e6e22b86222a	2024-05-02	Warnings	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	Fresenius Kabi USA, LLC	c2467d57-cd2d-4409-bcc0-50128bd01bba	2024-04-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Mineffect eye drops	ALUMINA SILICATA, CALCAREA FLUORICA, FERRUM METALLICUM, FERRUM PHOSPHORICUM, NATRUM MURIATICUM, PHOSPHORUS, SULPHUR, TITANIUM METALLICUM, ZINCUM METALLICUM	Kadesh Incoporation Co,Ltd	e2259f58-3043-4af3-918d-d4403757aa1f	2024-04-26	Warnings	Exact identifier unii: 451W47IQ8X unii: J41CSQ7QDS
LACTATED RINGERS	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Fresenius Kabi USA, LLC	7a723a23-3bc1-4f69-b82f-d06a35dc68d6	2024-04-24	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
VACC HC	HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM, ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUM	Deseret Biologicals, Inc.	a98082ba-21ec-4cf8-b81c-bcb41eb9fd12	2024-04-23	Warnings	Exact identifier unii: J41CSQ7QDS
Sodium chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	c1e52670-c85e-4f19-a2e9-bf9abd7c3727	2024-04-23	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Glyreg	ACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCA	Deseret Biologicals, Inc	28e670ca-ed35-4256-af20-74c25dc18099	2024-04-23	Warnings	Exact identifier unii: J41CSQ7QDS

Reported adverse events (FAERS/openFDA)#

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