FDA.reportPublic FDA data

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
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
0944-0495-05Flexbumin2 in 1 CARTONINJECTION, SOLUTION214
0944-0495-06Flexbumin250 mL in 1 BAGINJECTION, SOLUTION25014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0944-0495FLEXBUMIN (ALBUMIN HUMAN) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]14Current NDC, Legacy NDC, 2 package rows20241222_79094f4e-5f5c-44d6-b563-d6078eafe83a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0944-0495-05ML - Milliliter0944-0495e6b5163d-2d6e-48d4-82f5-00370a448dea12014-11-05
0944-0495-06ML - Milliliter0944-049573e9eb05-b979-44c1-b952-01d90fea11fb12024-01-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUMIN HUMANACTIVE INGREDIENTZIF514RVZRFLEXBUMIN (ALBUMIN HUMAN) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]1
ALBUMIN HUMANACTIVE MOIETYZIF514RVZRFLEXBUMIN (ALBUMIN HUMAN) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]1
SODIUM ACETYLTRYPTOPHANATEINACTIVE INGREDIENT3EN9H0M2FXFLEXBUMIN (ALBUMIN HUMAN) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]1
SODIUM CAPRYLATEINACTIVE INGREDIENT9XTM81VK2BFLEXBUMIN (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 1 of 2 · 28 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
Sodium AcetateSODIUM ACETATEMILLA PHARMACEUTICALS INC.1ea1466d-a492-4056-e063-6394a90a80bf2026-01-07Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
PerikabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCc2eb5522-8572-45f4-869d-42f9fd251bb62025-09-15Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
KabivenDEXTROSE, SOYBEAN OIL, ELECTROLYTES, LYSINE, PHENYLALANINE, LEUCINE, VALINE, THREONINE, METHIONINE, ISOLEUCINE, TRYPTOPHAN, ALANINE, ARGININE, GLYCINE, PROLINE, HISTIDINE, GLUTAMIC ACID, SERINE, ASPARTIC ACID AND TYROSINEFresenius Kabi USA, LLCafeb4837-a759-4484-a76e-e04611c459e72025-09-11Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Sodium AcetateSODIUM ACETATEMILLA PHARMACEUTICALS INC.1ea04916-78e5-4651-e063-6394a90ac4be2025-01-16Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
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
Plasma-Lyte 148 (pH 7.4)SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDEBaxter Healthcare Corporationfe935c8d-f42d-42e4-8665-0dc66829f2312024-11-08Exact identifier
unii: 4550K0SC9B
SODIUM ACETATESODIUM ACETATEFresenius Kabi USA, LLCd7fabf08-d4e0-4bb5-8416-2e8ffe27c04b2024-10-11Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Isolyte P in DextroseDEXTROSE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND POTASSIUM PHOSPHATE, DIBASICB. Braun Medical Inc.4ea4397c-2fa4-4670-91e6-21ae498c88f72024-06-24Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Balanced SaltSODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATEB. Braun Medical Inc.74ab8883-0a5f-46b4-8998-9358f6fd4ef42024-03-13Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea2024-01-25Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
BSSBALANCED SALT SOLUTIONAlcon Laboratories, Inc.28488c7b-cf6a-4a03-916f-cc66b3afdc572023-12-14Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Isolyte S pH 7.4SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM PHOSPHATE, DIBASIC, AND POTASSIUM PHOSPHATEB. Braun Medical Inc.150437b6-320e-4c69-a434-2a26a1f0b2e42023-10-06Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
PhysiolyteSODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDEB. Braun Medical Inc.19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e2023-09-26Warnings, Adverse reactionsExact identifier
unii: 4550K0SC9B
Natrum AceticumNATRUM ACETICUMHahnemann Laboratories, INC.04cdea6c-8348-d855-e063-6294a90a66602023-09-07Exact identifier
unii: 4550K0SC9B

Reported adverse events (FAERS/openFDA)#

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