FDA.reportPublic FDA data

NDC 0944-0493-03 - 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
0944-0493
Requested NDC
0944-0493-03
Package NDCs from labels
0944-0493-03, 0944-0493-01, 0944-0493-04, 0944-0493-02
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
LabelManufacturerEffective dateType
FLEXBUMINTakeda Pharmaceuticals America, Inc. | BAXALTA INCORPORATED | Baxalta US Inc.2024-12-18PLASMA DERIVATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-0493-01FLEXBUMIN12 in 1 CARTONSOLUTION1217
0944-0493-02FLEXBUMIN6 in 1 CARTONSOLUTION617
0944-0493-03FLEXBUMIN50 mL in 1 BAGSOLUTION5017
0944-0493-04FLEXBUMIN100 mL in 1 BAGSOLUTION10017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-0493FLEXBUMIN (ALBUMIN HUMAN) SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]17Current NDC, Legacy NDC, 4 package rows20241222_bdb4e167-27a2-4b50-b245-43df9cd535cb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0944-0493-01ML - Milliliter0944-0493a88a1257-57d4-4d9f-a61a-f5806367e6e712012-07-24
0944-0493-02ML - Milliliter0944-04930f322d7d-2ff7-4a46-b1c0-f43a93fb62f312012-07-24
0944-0493-03ML - Milliliter0944-0493bb99283c-302f-426c-b2d2-bb3bc95421e912024-02-14
0944-0493-04ML - Milliliter0944-0493a9527945-e3ad-4bc7-8a8b-553a00ab954f12024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUMIN HUMANACTIVE INGREDIENTZIF514RVZRFLEXBUMIN (ALBUMIN HUMAN) SOLUTION [BAXTER HEALTHCARE CORPORATION]4
ALBUMIN HUMANACTIVE MOIETYZIF514RVZRFLEXBUMIN (ALBUMIN HUMAN) SOLUTION [BAXTER HEALTHCARE CORPORATION]4
SODIUM ACETYLTRYPTOPHANATEINACTIVE INGREDIENT3EN9H0M2FXFLEXBUMIN (ALBUMIN HUMAN) SOLUTION [BAXTER HEALTHCARE CORPORATION]4
SODIUM CAPRYLATEINACTIVE INGREDIENT9XTM81VK2BFLEXBUMIN (ALBUMIN HUMAN) SOLUTION [BAXTER HEALTHCARE CORPORATION]4

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 1 of 1 ยท 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WHWSWB 0.9% SalineSODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd4e9c21e5-f2f9-90e4-e063-6394a90acfe22026-07-11WarningsExact identifier
unii: LYR4M0NH37
Spa/Pool Detox 6027SPA/POOL DETOXProfessional Complementary Health Formulas14b8fca2-089d-44f7-8b70-ee877c8f7af12026-01-08WarningsExact identifier
unii: LYR4M0NH37
Radialgin 6002RADIALGINProfessional Complementary Health Formulas5e7ce7a0-9f43-4a69-89e9-a59692a8de412026-01-08WarningsExact identifier
unii: LYR4M0NH37
Proteinuria Drops 2053PROTEINURIA DROPSProfessional Complementary Health Formulas1bf80282-8283-4835-acd4-fbdb47788c672026-01-08WarningsExact identifier
unii: ZIF514RVZR
ALBUMINEXALBUMIN HUMANBPL8428d373-f4b1-4e3b-bb19-ea89048f7c792024-12-31Warnings, Adverse reactionsExact identifier
unii: ZIF514RVZR
ALBUMINEXALBUMIN HUMANBPL167f48d0-8ae5-4f7e-b050-9673dad78acc2024-12-31Warnings, Adverse reactionsExact identifier
unii: ZIF514RVZR

Reported adverse events (FAERS/openFDA)#

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