NDC 0944-4139-01 - ADYNOVATE

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: 0944-4139
Requested NDC: 0944-4139-01
Package NDCs from labels: 0944-4139-01
Manufacturer: Takeda Pharmaceuticals Amercia, Inc. | BAXALTA US INC. | Siegfried Hameln GmbH | Takeda Manufacturing Austria AG | Baxalta Belgium Manufacturing SA | Baxalta Manufacturing Sàrl | Takeda Manufacturing Singapore Pte. Ltd.
Effective date: 2026-05-28
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ADYNOVATE	Takeda Pharmaceuticals Amercia, Inc. \| BAXALTA US INC. \| Siegfried Hameln GmbH \| Takeda Manufacturing Austria AG \| Baxalta Belgium Manufacturing SA \| Baxalta Manufacturing Sàrl \| Takeda Manufacturing Singapore Pte. Ltd.	2026-05-28	PLASMA DERIVATIVE
ADYNOVATE - BAXALTA US INC. \| Baxalta Belgium Manufacturing SA \| Siegfried Hameln GmbH	BAXALTA US INC. \| Baxalta Belgium Manufacturing SA \| Siegfried Hameln GmbH	2018-06-26	PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0944-4139-01	ADYNOVATE	5 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	5 mL	750 [iU] in 2mL	23

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0944-4139	ADYNOVATE (ANTIHEMOPHILIC FACTOR (RECOMBINANT) PEGYLATED) KIT [TAKEDA PHARMACEUTICALS AMERCIA, INC.]	22	Unmatched	20250331_ef290433-997f-4e98-86d6-42f6a99d6d18.zip

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 53 of 53 · 1,043 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Join
TIS-U-SOL	SODIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM SULFATE, SODIUM PHOSPHATE, AND POTASSIUM PHOSPHATE	Baxter Healthcare Corporation	9da4121f-d62d-4da4-8dfb-0494da16015f	2014-02-21	Exact identifier unii: 451W47IQ8X
Ringers	SODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE,	Baxter Healthcare Corporation	e1953d54-818d-46a6-8532-518ebae6d84e	2012-06-13	Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12	Exact identifier unii: 451W47IQ8X unii: M4I0D6VV5M

Reported adverse events (FAERS/openFDA)#

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