NDC 0944-3941 - 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: 0944-3941
Package NDCs from labels: 0944-3941-01
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
Label	Manufacturer	Effective date	Type
HEMOFIL M - Takeda Pharmaceuticals America, Inc. \| BAXALTA US Inc.	Takeda Pharmaceuticals America, Inc. \| BAXALTA US Inc.	2025-03-06	PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0944-3941-01	HEMOFIL M	10 mL in 1 BOTTLE	POWDER, FOR SOLUTION	10 mL	250 [iU] in 10mL	15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0944-3941	HEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [TAKEDA PHARMACEUTICALS AMERICA, INC.]	15	Unmatched	20250309_b8953ff7-3bba-4a0b-a486-f26fb81f05d9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ANTIHEMOPHILIC FACTOR HUMAN	ACTIVE INGREDIENT	839MOZ74GK	HEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	9
ANTIHEMOPHILIC FACTOR HUMAN	ACTIVE MOIETY	839MOZ74GK	HEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	9
ALBUMIN HUMAN	INACTIVE INGREDIENT	ZIF514RVZR	HEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	9
HISTIDINE	INACTIVE INGREDIENT	4QD397987E	HEMOFIL M (ANTIHEMOPHILIC FACTOR HUMAN) KIT [BAXTER HEALTHCARE CORPORATION]	9
POLYETHYLENE GLYCOL 3350	INACTIVE INGREDIENT	G2M7P15E5P	HEMOFIL 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 15 of 15 · 285 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bio Rock Water	ROCK WATER	BioActive Nutritional, Inc.	178bd16d-0d4f-49d8-866b-8ab3a3c6889d	2018-07-30	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Baxter Healthcare Corporation	ef3e79c5-3f58-4b36-a296-64b7d9a651c1	2017-10-17	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eye Wash	WATER	CVS Pharmacy	049cee29-7ec2-4d5b-8308-f522acde43a7	2017-03-29	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
7c490b0a-7412-407b-823e-e7e0e8ad4011			b8953ff7-3bba-4a0b-a486-f26fb81f05d9	2011-03-15	Warnings, Adverse reactions	Exact identifier spl set id: b8953ff7-3bba-4a0b-a486-f26fb81f05d9

Reported adverse events (FAERS/openFDA)#

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