FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
OBIZURTakeda Pharmaceuticals America, Inc. | Vetter Pharma Fertigung GmbH & Co. KG | Baxter Aktiengesellschaft (AG) | PPD Labs | Baxalta Manufacturing Sàrl2025-03-05PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-5011-01OBIZUR1 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,1 mL500 [USP'U] in 1mL18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-5011OBIZUR (ANTIHEMOPHILIC FACTOR (RECOMBINANT), PORCINE SEQUENCE) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]18Unmatched20250309_a69ccbb3-7648-4978-8c6d-7ca6b95a9b01.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANTACTIVE INGREDIENT6892UQT2GKOBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]1
ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANTACTIVE MOIETY6892UQT2GKOBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]1
CALCIUM CHLORIDEINACTIVE INGREDIENTM4I0D6VV5MOBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XOBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULROBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]1
SUCROSEINACTIVE INGREDIENTC151H8M554OBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]1
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2VOBIZUR (ANTIHEMOPHILIC FACTOR PORCINE, B-DOMAIN TRUNCATED RECOMBINANT) KIT [BAXTER HEALTHCARE CORPORATION]1
TROMETHAMINE HYDROCHLORIDEINACTIVE INGREDIENT383V75M34EOBIZUR (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 32 of 56 · 1,119 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst7610bf80-61b7-982f-e053-2a91aa0ac1bb2025-01-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
A-5SUCROSEDNA Labs, Inc.8e63f697-26c1-4518-acd3-5ea72cfa27f72025-01-09WarningsExact identifier
unii: C151H8M554
A-36BOS TAURUS ADRENAL GLAND, AGRIMONIA EUPATORIA, BELLIS PERENNIS, CAMPHOR (NATURAL), MATRICARIA CHAMOMILLA, EQUISETUM HYEMALE, FRAXINUS AMERICANA BARK, FORMICA RUFA, HISTAMINE DIHYDROCHLORIDE, IODINE, POTASSIUM DICHROMATE, CANIS LUPUS FAMILIARIS MILK, SODIUM CHLORIDE, ANEMONE PULSATILLA, SALIX NIGRA BARK, AND TOBACCO LEAFDNA Labs, Inc.161c4738-9ead-4687-9f5a-029d5a496e072025-01-09WarningsExact identifier
unii: 451W47IQ8X
AM-11ARNICA MONTANA, SODIUM CHLORIDE, AND APIS MELLIFERADNA Labs, Inc.c072811b-6259-4b22-b364-50369dc68fb02025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-13CEANOTHUS AMERICANUS LEAF, URTICA URENS, SODIUM CHLORIDE, LACHESIS MUTA WHOLE, CINCHONA OFFICINALIS BARK, LYCOPODIUM CLAVATUM WHOLE, FERRIC CHLORIDE HEXAHYDRATE, AND SUS SCROFA SPLEENDNA Labs, Inc.146c5465-bcd9-4057-8975-dc1088b9971b2025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-10SODIUM CHLORIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, SEPIA OFFICINALIS JUICE, IODINE, LYCOPODIUM CLAVATUM WHOLE, AND BOS TAURUS PITUITARY GLAND, POSTERIORDNA Labs, Inc.264d8093-70f3-43a5-bfc4-b719bb3e45e62025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-16MGO ENERGIZERDNA Labs, Inc.8292b900-86c1-47ea-81da-b587439c76642025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-21CALCIUM FLUORIDE, SILICON DIOXIDE, EUPHRASIA STRICTA, RUTA GRAVEOLENS WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, PHYSOSTIGMA VENENOSUM WHOLE, ANEMONE PULSATILLA, SODIUM CHLORIDE, AND SUS SCROFA EYEDNA Labs, Inc.89967941-c4ee-4598-a66d-8a93d69a4d652025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-14FUCUS VESICULOSUS, SODIUM CHLORIDE, LYCOPUS VIRGINICUS, SPONGIA OFFICINALIS SKELETON, ROASTED, POTASSIUM IODIDE, CALCIUM IODIDE, THYROID, UNSPECIFIED, BOS TAURUS ADRENAL GLAND, BOS TAURUS PITUITARY GLAND, POSTERIOR, BOS TAURUS THYMUS, AND SUS SCROFA SPLEENDNA Labs, Inc.3d64739c-5d61-4e88-8612-d5f6994f1c3c2025-01-09WarningsExact identifier
unii: 451W47IQ8X
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: 451W47IQ8X
T-27WATERDNA Labs, Inc.f0e9afd7-64a4-4b85-9c5f-4bf07ba4b4812025-01-09WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterSTERILE WATER FOR INJECTIONMedefil, Inc.99e99a50-82d5-aff6-e053-2a95a90a8c562025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC WATERBACTERIOSTATIC WATERHF Acquisition Co LLC, DBA HealthFirst99b0ef9b-600a-40dc-e053-2a95a90aa07e2025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
0.9% SODIUM CHLORIDE0.9% SODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst8dfb05c0-77e8-2fa1-e053-2a95a90a3d332025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
STERILE WATERSTERILE WATERHF Acquisition Co LLC, DBA HealthFirst99b1cb12-0b2d-0c0f-e053-2a95a90ac3b62025-01-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst998a2a47-5c79-2efd-e053-2995a90a8fac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
SODIUM CHLORIDESODIUM CHLORIDEHF Acquisition Co LLC, DBA HealthFirst7da788fc-3481-527f-e053-2a91aa0af6ac2025-01-08Adverse reactionsExact identifier
unii: 451W47IQ8X
Dextrose and Sodium ChlorideDEXTROSE MONOHYDRATE AND SODIUM CHLORIDEBECTON DICKINSON AND COMPANYc1d0f42e-3494-4217-8f86-e9f34d930e822025-01-07Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Shingles RemedyCROTON TIGLIUM, NATRUM MURIATICUM, PLANTAGO MAJOR, RHUS TOX, SARSAPARILLASilver Star Brands5d65c997-f5dc-4dee-e053-2a91aa0ac3192025-01-01WarningsExact identifier
unii: 451W47IQ8X
Mucus Clear Allergy ReliefALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICASilver Star Brandsf49bdcc1-1939-6dc2-e053-2995a90a0a3b2025-01-01WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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