NDC 0944-0011 - 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: 0944-0011
Package NDCs from labels: 0944-0011-01
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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0944-0011	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 48 of 54 · 1,068 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Natrium Muriaticum 6X	SODIUM CHLORIDE	Seroyal USA	0ebf18de-12fe-0bc4-e054-00144ff88e88	2022-07-07	Warnings	Exact identifier unii: 451W47IQ8X
REFRESH Optive Mega-3	CARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN AND POLYSORBATE 80	Allergan, Inc.	c5f2b3f2-2071-45bd-a010-67f848bc0233	2022-06-30	Warnings	Exact identifier unii: 6OZP39ZG8H
Erogetone	ARALIA QUINQUEFOLIA, BERBERIS VULGARIS, CAUSTICUM, CONIUM MACULATUM, DAMIANA, GRAPHITES, LACHESIS MUTUS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SEPIA	Energique, Inc.	1e872ecd-e7a5-463d-9832-47b7046096db	2022-06-28	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	Fresenius Kabi USA, LLC	f42ac50f-0ec5-4713-a4c8-99d972d90bed	2022-06-22	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Fresenius Kabi USA, LLC	e71c6c83-d518-496c-b2ab-efd5987e4783	2022-06-09	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Cardioplegic Solution	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE	Fresenius Kabi, USA, LLC	eb360dc4-88d6-4b28-9b61-bc359e16bd22	2022-05-27	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
Calcarea Muriatica	CALCAREA MURIATICA	Hahnemann Laboratories, INC.	df517477-164b-33cc-e053-2a95a90a2083	2022-05-18		Exact identifier unii: M4I0D6VV5M
Addiclenz	BETA VULGARIS, BOLDO, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM	Deseret Biologicals, Inc.	e39235ea-2a2f-44a7-92d6-fb1d428ebabd	2022-05-12	Warnings	Exact identifier unii: 1Q73Q2JULR
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	24a08a93-df23-474b-873e-c59ec8855f9f	2022-03-14	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Wild Horse 777 Moisturizing Nasal	SODIUM CHLORIDE	Wild Horse 777, Inc.	b0b4dadd-11fa-3dbb-e053-2995a90a2097	2022-03-14	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	cc14fafd-3dcd-4fc8-bdbd-6f355c375768	2022-02-23	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	8b44bfd3-70a4-4b47-bc7b-590f63b8cc75	2022-02-15	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
ACNE HP	CARBO ANIMALIS, ACTIVATED CHARCOAL, POTASSIUM DICHROMATE, SODIUM CHLORIDE, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, SULFUR, ZINC	Natural Creations, Inc.	b2368ab6-e233-4473-99fa-86e1fbc2a879	2022-02-14	Warnings	Exact identifier unii: 451W47IQ8X
ACD-A	ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A	Fenwal, Inc.	22805f0d-ba58-41ea-b245-19980abcda22	2022-02-11		Exact identifier unii: 1Q73Q2JULR
Sodium Chloride	SODIUM CHLORIDE	Fresenius Kabi USA, LLC	f62481fd-fcdb-4be6-ac13-29c590e925c3	2022-02-10	Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Water	WATER	American Regent, Inc.	78b35864-4bbc-4759-a5c1-7e4f25e22932	2022-01-31	Boxed warning	Exact identifier unii: 059QF0KO0R
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	e44c41ae-c9c8-4dd8-ba6c-cebb585378aa	2022-01-31	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sterile Saline Mist Walgreens	SODIUM CHLORIDE	WALGREEN COMPANY	d6b9d4fc-b758-be32-e053-2995a90a2523	2022-01-29	Warnings	Exact identifier unii: 451W47IQ8X
Extra Strenght Saline Mist Rite Aid	SODIUM CHLORIDE	RITE AID CORPORATION	d5b30fb2-4052-4a0c-e053-2a95a90aacd5	2022-01-16	Warnings	Exact identifier unii: 451W47IQ8X
Sterile Saline Mist Rite Aid	SODIUM CHLORIDE	RITE AID	d583067e-1133-7d7d-e053-2a95a90a1e36	2022-01-13	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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