NDC 0944-5011 - OBIZUR

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: 0944-5011
Package NDCs from labels: 0944-5011-01
Manufacturer: Takeda Pharmaceuticals America, Inc. | Vetter Pharma Fertigung GmbH & Co. KG | Baxter Aktiengesellschaft (AG) | PPD Labs | Baxalta Manufacturing Sàrl
Effective date: 2025-03-05
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
OBIZUR	Takeda Pharmaceuticals America, Inc. \| Vetter Pharma Fertigung GmbH & Co. KG \| Baxter Aktiengesellschaft (AG) \| PPD Labs \| Baxalta Manufacturing Sàrl	2025-03-05	PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0944-5011-01	OBIZUR	1 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	1 mL	500 [USP'U] in 1mL	18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0944-5011	OBIZUR (ANTIHEMOPHILIC FACTOR (RECOMBINANT), PORCINE SEQUENCE) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	18	Unmatched	20250309_a69ccbb3-7648-4978-8c6d-7ca6b95a9b01.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT	ACTIVE INGREDIENT	6892UQT2GK	OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	1
ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT	ACTIVE MOIETY	6892UQT2GK	OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	1
CALCIUM CHLORIDE	INACTIVE INGREDIENT	M4I0D6VV5M	OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	1
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	1
SUCROSE	INACTIVE INGREDIENT	C151H8M554	OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	1
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	1
TROMETHAMINE HYDROCHLORIDE	INACTIVE INGREDIENT	383V75M34E	OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]	1

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 33 of 56 · 1,119 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sweat-Less	ARG NIT, CASTOREUM, HUMULUS, IODUM, KALI PHOS, NAT MUR	Silver Star Brands	4053d10b-4b06-291b-e054-00144ff88e88	2025-01-01	Warnings	Exact identifier unii: 451W47IQ8X
NativeRemedies Triple Complex Brain Tonic	CALC PHOS, KALI PHOS, NAT MUR.	Silver Star Brands	f76eaf46-4a80-31a9-e053-6394a90a542d	2025-01-01	Warnings	Exact identifier unii: 451W47IQ8X
Headache Ease	AUR MET, BELLADONNA, BRYONIA, GELSEISUM, IGNATIA, KALI PHOS, NAT MUR, NUX VOM, SEPIA	Silver Star Brands	c689fb16-6200-ac94-e053-2995a90a703d	2025-01-01	Warnings	Exact identifier unii: 451W47IQ8X
AllergiClear-M	ADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEA	Silver Star Brands	9d36096b-022f-5cfa-e053-2995a90a381f	2025-01-01	Warnings	Exact identifier unii: 451W47IQ8X
DG Health Sterile Saline Mist	SODIUM CHLORIDE	DG Health	f2e44ab4-ae0f-c87b-e053-2a95a90acd04	2024-12-31	Warnings	Exact identifier unii: 451W47IQ8X
Gut Brain Spectrum	ABROTANUM (ARTEMISIA ABROTANUM), AETHUSA CYNAPIUM, BAPTISIA TINCTORIA, CICUTA VIROSA, CUPRUM METALLICUM, MEZEREUM, BUFO RANA, LAC MATERNA HUMANUM, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), ALUMINA, CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CARCINOSIN, LAC CANINUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, PROPIONIC ACID, SULPHUR, THUJA OCCIDENTALIS, FORMALINUM, MORBILLINUM	Energique, Inc.	adfee6ce-05b0-4955-bf5f-9612b8db4c78	2024-12-26	Warnings	Exact identifier unii: C151H8M554 unii: 451W47IQ8X
TREE ANTIGEN	POPULUS TRISTIS POLLEN, JUGLANS NIGRA POLLEN, ACER NEGUNDO POLLEN, ALNUS RUBRA POLLEN, JUNIPERUS VIRGINIANA POLLEN, ULMUS RUBRA POLLEN, ACER PSEUDOPLANUS POLLEN, FRAXINUS AMERICANA POLLEN, CARYA TOMENTOSA POLLEN, ONION, ARSENIC TRIOXIDE, ATROPA BELLADONNA, ACTIVATED CHARCOAL, EUPHRASIA OFFICINALIS, LYCOPODIUM CLAVITUM SPORE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSITILLA VULGARIS WHOLE	Natural Creations, Inc	8040ab36-90eb-4076-a478-9b82ccfa4ec9	2024-12-23	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Hypertonic Saline Solution 7 Sodium Chloride	SODIUM CHLORIDE	JOONEM LLC	e7110525-9f9b-5b68-e053-2995a90ac034	2024-12-23	Warnings	Exact identifier unii: 451W47IQ8X
Base Laboratories Saline	SODIUM CHLORIDE	Joonem LLC	49309411-9af4-4f19-a3bf-dbeabc106827	2024-12-23	Warnings	Exact identifier unii: 451W47IQ8X
Base Laboratories Saline	SODIUM CHLORIDE	Joonem LLC	ba0868f6-d3de-40e2-bcb3-144fa53062c7	2024-12-23	Warnings	Exact identifier unii: 451W47IQ8X
Base Laboratories Saline	SODIUM CHLORIDE	Joonem LLC	9d83f477-ebbc-4248-8445-769178181d4f	2024-12-23	Warnings	Exact identifier unii: 451W47IQ8X
TROMETHAMINE	TROMETHAMINE	B. Braun Medical Inc.	57db5686-7f7f-4999-87e3-e1cbbda4a98d	2024-12-23	Warnings, Adverse reactions	Exact identifier unii: 023C2WHX2V
Calcium Chloride	CALCIUM CHLORIDE	Dr. Reddy's Laboratories Inc.	7e94daf8-b71f-49d9-af3f-3a78ae9dfc8a	2024-12-19	Warnings, Adverse reactions	Exact identifier unii: M4I0D6VV5M
Trace Mineral Cord	ARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,	Energique, Inc.	902dd68d-5ce1-481e-8938-6487dcc68dfc	2024-12-19	Warnings	Exact identifier unii: 451W47IQ8X
Calcium Chloride Dihydrate	CALCIUM CHLORIDE DIHYDRATE	Somerset Therapeutics, LLC	8f22eef7-cb4b-41c9-9fe4-7010aadf2164	2024-12-19	Warnings, Adverse reactions	Exact identifier unii: M4I0D6VV5M
Ancient Secrets Breathe Again	SODIUM CHLORIDE	LOTUS BRANDS, INC.	c6d2bab0-d363-4c09-a71b-ae15db915b37	2024-12-18	Warnings	Exact identifier unii: 451W47IQ8X
Walgreens Saline Mist Extra Strength	SODIUM CHLORIDE	Walgreen's Corporation	90cbe2dc-36b6-77fb-e053-2995a90a2897	2024-12-18	Warnings	Exact identifier unii: 451W47IQ8X
CVS Health Sterile Saline Mist	SODIUM CHLORIDE	CVS Pharmacy	6f1fe980-ca09-401d-aed6-d3d3387cc49a	2024-12-18	Warnings	Exact identifier unii: 451W47IQ8X
Mast Cell Pro	HYDRASTIS CANADENSIS, ASCORBICUM ACIDUM, CINCHONA OFFICINALIS, KIDNEY (SUIS), THIAMINUM HYDROCHLORICUM, URTICA DIOICA, APIS MELLIFICA, ARSENICUM ALBUM, BOVISTA, CARBOLICUM ACIDUM, COFFEA CRUDA, HISTAMINUM HYDROCHLORICUM, LACHESIS MUTUS, LEDUM PALUSTRE, NUX VOMICA, OXALICUM ACIDUM, PHOSPHORUS, RHUS TOX, SARCOLACTICUM ACIDUM, SECALE CORNUTUM, SEPIA, SEROTONIN (HYDROCHLORIDE), SULPHUR, THUJA OCCIDENTALIS, VENUS MERCENARIA, ACONITUM NAPELLUS, CALADIUM SEGUINUM, IGNATIA AMARA, NATRUM MURIATICUM,	Energique, Inc.	5cd31e1d-0312-48d1-9ecd-d01c6fe3b672	2024-12-11	Warnings	Exact identifier unii: 451W47IQ8X
Fendall Pure Flow	PURIFIED WATER	Honeywell Safety Products USA, Inc.	afda6fc3-7615-b0be-e053-2995a90a6208	2024-12-10	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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