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 23 of 56 · 1,119 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gout Relief 3310-S	CELERY SEED, MEDICAGO SATIVA WHOLE,CHICORY ROOT	Bispit Canada Ltd.	3afaa7d9-3de3-52d9-e063-6294a90a54ec	2025-08-02	Warnings	Exact identifier unii: 451W47IQ8X
QUALITY CHOICE SALINE	PLUS SOOTHING ALOE	QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)	4ae4e88a-aaa5-4195-bedc-622fd5cd9394	2025-07-30	Warnings	Exact identifier unii: 451W47IQ8X
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	9e72418a-376e-4637-99ad-d13c904a7986	2025-07-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Cell Salts	CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA	Newton Laboratories, Inc.	985a3341-0fe0-1dd6-e053-2a95a90ad2c5	2025-07-25	Warnings	Exact identifier unii: 451W47IQ8X
Dairy-Grain-Nightshade	IRIS VERS., SOLIDAGO, ANTIMON. CRUD., ARG. NIT., ARSENICUM ALB., AVENA, BAPTISIA, BELLADONNA, BRYONIA, CAPSICUM, CARDUUS BEN., CINCHONA, DULCAMARA, FAGOPYRUM, GELSEMIUM, HYOSCYAMUS, IPECAC., LAC VAC., LACHESIS, LYCOPODIUM, NAT. MUR., PHOS., PODOPH. PELT., PULSATILLA, RHUS TOX., SAC. LAC., SECALE, SEPIA, STRAMONIUM, TABACUM, TRITICUM, USTILAGO MAIDIS, VERBASCUM, LYCOPERSICUM, SOLANUM NIG., SOLANUM TUB., STIGMATA, TORULA CEREVISIAE.	Newton Laboratories, Inc.	99fcbd61-ecc8-cf9d-e053-2995a90aebeb	2025-07-25	Warnings	Exact identifier unii: 451W47IQ8X
Bedwetting	ECHINACEA, HYDRASTIS CANADENSIS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, BELLADONNA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PLANTAGO MAJOR, PULSATILLA, RHUS AROMATICA, SABAL SERRULATA, THYROIDINUM, VERBASCUM THAPSUS	Newton Laboratories, Inc.	9d5f51d0-01e9-271c-e053-2995a90a63bc	2025-07-24	Warnings	Exact identifier unii: 451W47IQ8X
Bedwetting	ECHINACEA, HYDRASTIS CANADENSIS, PASSIFLORA INCARNATA, VALERIANA OFFICINALIS, BELLADONNA, CANTHARIS, CAUSTICUM, EQUISETUM HYEMALE, FERRUM METALLICUM, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, PLANTAGO MAJOR, PULSATILLA, RHUS AROMATICA, SABAL SERRULATA, THYROIDINUM, VERBASCUM THAPSUS	Newton Laboratories, Inc.	9d6058a0-69dd-66d0-e053-2a95a90a58f8	2025-07-24	Warnings	Exact identifier unii: 451W47IQ8X
Cell Salts	CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA	Newton Laboratories, Inc.	7a1b4e96-c96f-6424-e053-2991aa0aef30	2025-07-24	Warnings	Exact identifier unii: 451W47IQ8X
Cell Salts	CALC. FLUOR., CALC. PHOS., CALC.SULPH., FERRUM PHOSPHORICUM, KALI MUR., KALI PHOS., KALI SULPH., MAG. PHOS., NAT. MUR., NAT. PHOS., NAT.SULPHURICUM, SILICEA	Newton Laboratories, Inc.	7a1a9ef9-9a54-5f94-e053-2a91aa0ab477	2025-07-24	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	Nextgen Pharmaceuticals LLC	28f79c75-82d2-4912-81fc-a723b5ccf4c1	2025-07-23	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
BACTERIOSTATIC SODIUM CHLORIDE	SODIUM CHLORIDE	ProPharma Distribution	3868864f-4f46-d2a1-e063-6394a90a65d5	2025-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Aller-Chord F	ACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.	Energetix Corporation	ff4eb7b2-8272-4bd3-99a9-7e589b30d59a	2025-07-15	Warnings	Exact identifier unii: C151H8M554 unii: 451W47IQ8X
Sterile Water	STERILE WATER	Nephron Pharmaceuticals Corporation	bc04a883-babc-87a6-e053-2995a90a3dfd	2025-07-11	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
HerpaOne	GRAPHITE, SODIUM CHLORIDE, SYMPHYTUM OFFICINALE WHOLE, THUJA OCCIDENTALIS LEAFY TWIG	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	6b196d97-6446-4651-97ef-6615cf3e3173	2025-07-11	Warnings	Exact identifier unii: 451W47IQ8X
POTASSIUM CHLORIDE IN SODIUM CHLORIDE	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	B. Braun Medical Inc.	ecc38772-246a-46c4-b42a-b9b81124f27f	2025-07-11	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Leader Sinus Wash Saline Refill Packets	SODIUM BICARBONATE, SODIUM CHLORIDE	Cardinal Health, 110 dba LEADER	fb192a6d-318e-4d2b-89b6-42ac023e4fbd	2025-07-09	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	B. Braun Medical Inc.	0d59a04a-32e6-485b-b638-a1e6c09e9642	2025-07-09	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Schuessler Tissue Salts Nat Mur Fluid Balance 9	NATRUM MURIATICUM	Martin & Pleasance Pty Ltd	0b21c366-fff6-4754-a671-35481ec2c4bd	2025-07-07	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Citrate and Citric Acid	SODIUM CITRATE AND CITRIC ACID MONOHYDRATE	Belleview Biosciences LLC	3245e0e5-5e7f-c3f7-e063-6394a90ac258	2025-07-07	Adverse reactions	Exact identifier unii: 1Q73Q2JULR
Normal Salt	SODIUM CHLORIDE	Twin Med LLC	dc82ff0f-8600-373a-e053-2995a90a7505	2025-07-03	Warnings	Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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