NDC 0944-0495-06 - Flexbumin

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: 0944-0495
Requested NDC: 0944-0495-06
Package NDCs from labels: 0944-0495-06, 0944-0495-05
Manufacturer: Takeda Pharmaceuticals America, Inc. | BAXALTA INCORPORATED | Baxalta US Inc.
Effective date: 2024-12-18
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Flexbumin	Takeda Pharmaceuticals America, Inc. \| BAXALTA INCORPORATED \| Baxalta US Inc.	2024-12-18	PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0944-0495-05	Flexbumin	2 in 1 CARTON	INJECTION, SOLUTION	2		14
0944-0495-06	Flexbumin	250 mL in 1 BAG	INJECTION, SOLUTION	250		14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0944-0495	FLEXBUMIN (ALBUMIN HUMAN) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]	14	Current NDC, Legacy NDC, 2 package rows	20241222_79094f4e-5f5c-44d6-b563-d6078eafe83a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0944-0495-05	ML - Milliliter	0944-0495	e6b5163d-2d6e-48d4-82f5-00370a448dea	1	2014-11-05
0944-0495-06	ML - Milliliter	0944-0495	73e9eb05-b979-44c1-b952-01d90fea11fb	1	2024-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALBUMIN HUMAN	ACTIVE INGREDIENT	ZIF514RVZR	FLEXBUMIN (ALBUMIN HUMAN) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	1
ALBUMIN HUMAN	ACTIVE MOIETY	ZIF514RVZR	FLEXBUMIN (ALBUMIN HUMAN) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	1
SODIUM ACETYLTRYPTOPHANATE	INACTIVE INGREDIENT	3EN9H0M2FX	FLEXBUMIN (ALBUMIN HUMAN) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	1
SODIUM CAPRYLATE	INACTIVE INGREDIENT	9XTM81VK2B	FLEXBUMIN (ALBUMIN HUMAN) INJECTION, SOLUTION [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 2 of 2 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Multiple Electrolytes pH 7.4	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Fresenius Kabi USA, LLC	84221110-b3f1-42f4-800c-ad1d3b330e9e	2022-11-10	Warnings, Adverse reactions	Exact identifier unii: 4550K0SC9B
Multiple Electrolytes pH 5.5	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Fresenius Kabi USA, LLC	cf1f5f15-d31d-4a02-8f7e-b289d5ad4b5c	2022-11-10	Warnings, Adverse reactions	Exact identifier unii: 4550K0SC9B
InterSol	PLATELET ADDITIVE 3	Fenwal, Inc.	e4f06c0b-7cb1-49c9-97a4-2cfc21298495	2021-11-16	Warnings, Adverse reactions	Exact identifier unii: 4550K0SC9B
Solucion InterSol	SOLUCION ADITIVA PARA PLAQUETAS 3	Fenwal, Inc.	d5eaf5f4-67d3-4475-af9a-f5b0f882f5d1	2021-10-04	Warnings, Adverse reactions	Exact identifier unii: 4550K0SC9B
CLINIMIX E	LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE, VALINE, HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE, SERINE, TYROSINE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE	Baxter Healthcare Company	8469d6fb-d6ef-476f-8cc3-0905192de0a8	2021-04-13	Warnings, Adverse reactions	Exact identifier unii: 4550K0SC9B
InterSol	PLATELET ADDITIVE 3	Fenwal, Inc.	a00c4a93-cde2-4753-81f7-0d6fee9fb690	2020-10-20	Warnings, Adverse reactions	Exact identifier unii: 4550K0SC9B
Isolyte S	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	B. Braun Medical Inc.	7e8fe27f-ff82-48c1-9bf6-3c589c8e985d	2020-05-14	Warnings, Adverse reactions	Exact identifier unii: 4550K0SC9B
Plasma-Lyte A	SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE AND MAGNESIUM CHLORIDE	Baxter Healthcare Corporation	6ec9e61c-2c26-402f-8604-f446b2e34058	2019-08-05	Warnings, Adverse reactions	Exact identifier unii: 4550K0SC9B

Reported adverse events (FAERS/openFDA)#

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