FDA.reportPublic FDA data

NDC 0944-3945 - HEMOFIL M

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
0944-3945
Package NDCs from labels
0944-3945-01
Manufacturer
Takeda Pharmaceuticals America, Inc. | BAXALTA US Inc.
Effective date
2025-03-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HEMOFIL M - Takeda Pharmaceuticals America, Inc. | BAXALTA US Inc.Takeda Pharmaceuticals America, Inc. | BAXALTA US Inc.2025-03-06PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-3945-01HEMOFIL M10 mL in 1 BOTTLEPOWDER, FOR SOLUTION10 mL1000 [iU] in 10mL15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-3945HEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]15Unmatched20250309_b8953ff7-3bba-4a0b-a486-f26fb81f05d9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANTIHEMOPHILIC FACTOR HUMANACTIVE INGREDIENT839MOZ74GKHEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]9
ANTIHEMOPHILIC FACTOR HUMANACTIVE MOIETY839MOZ74GKHEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]9
ALBUMIN HUMANINACTIVE INGREDIENTZIF514RVZRHEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]9
HISTIDINEINACTIVE INGREDIENT4QD397987EHEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]9
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PHEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]9

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 13 of 15 · 285 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterSTERILE WATERHikma Pharmaceuticals USA Inc.b20a28b0-7dfa-42eb-9177-ec256d5a5ef72023-05-08Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
dg health clearlaxPOLYETHYLENE GLYCOL 3350Dolgencorp Incffae36fd-2fb7-4afb-a7f8-29c700a477fb2023-05-04WarningsExact identifier
unii: G2M7P15E5P
Sterile WaterWATERCivica, Inc.3f49eedf-5bf5-4a95-b704-c956d860ca042023-04-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TreprostinilTREPROSTINILSandoz Inc473297ca-a872-4052-a053-87dc8f0d3c132023-04-06Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NOVOLOGINSULIN ASPARTNovo Nordisk3a1e73a2-3009-40d0-876c-b4cb2be56fc52023-02-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
laxativePOLYETHYLENE GLYCOL 3350Rite Aid Corporation3ebe9191-8e0a-41cf-b759-82ecce4f50e42023-02-10WarningsExact identifier
unii: G2M7P15E5P
POLYETHYLENE GLYCOL-3350 AND ELECTROLYTESPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESNovel Laboratories, Inc.29d821ff-389c-41fb-8a27-89bd3f022b822023-02-08Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
dg health clearlaxPOLYETHYLENE GLYCOL 3350Dolgencorp, LLC94280ce4-b2cf-451d-a660-b26ab1a2d3f02023-02-06WarningsExact identifier
unii: G2M7P15E5P
clearlaxPOLYETHYLENE GLYCOL 3350H E B0b4b752d-045d-4ff0-8e50-5607d1a841a72023-01-26WarningsExact identifier
unii: G2M7P15E5P
Good Sense Clear LaxPOLYETHYLENE GLYCOL 3350L. Perrigo Company435db89c-1e32-4da5-b7d0-15e4071627152023-01-24WarningsExact identifier
unii: G2M7P15E5P
RehydrateAVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORATUM, ULMUS FULVA, GLYCYRRHIZA GLABRA, SILICEA, PUERARIA LOBATA, CARLSBAD AQUA, ADENOSINUM TRIPHOSPHORICUM DINATRUM, GERMANIUM SESQUIOXIDE, HYDROGEN, OXYGEN, WIESBADENParaDocs All Natural, Inc.648fab10-c46b-420f-a42c-6642009d83fb2023-01-10WarningsExact identifier
unii: 059QF0KO0R
basic care clearlaxPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC21897170-0d5e-4326-bebf-10258e0aca822022-12-08WarningsExact identifier
unii: G2M7P15E5P
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350Geri-Care Pharmaceutical Corpf4c7eb80-d8d5-406d-90d0-9d17914d71f22022-11-24WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Gericare Pharmaceuticals5d0d2c14-24e6-45b4-92f6-4eaf5da72cdd2022-10-28WarningsExact identifier
unii: G2M7P15E5P
Sterile WaterWATERFresenius Kabi USA, LLCb45e9f1d-9c48-4b46-8541-d846b89540df2022-10-26Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye washPURIFIED WATERMcKessonbd089fde-24ba-4de5-e053-2995a90a39bb2022-10-18WarningsExact identifier
unii: 059QF0KO0R
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Equate ClearLAXPOLYETHYLENE GLYCOL 3350WALMART INC.c5c13378-3c08-415f-8ab4-8a18d6300ca82022-09-08WarningsExact identifier
unii: G2M7P15E5P
injoy constipation reliefPOLYETHYLENE GLYCOL 3350L. Perrigo Companyb2414517-04bf-4f29-951e-b867855078c32022-08-19WarningsExact identifier
unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

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