FDA.reportPublic FDA data

FLEXBUMIN

Product NDC
0944-0493
11-digit product format
009440493
Labeler code
0944
Product ID
0944-0493_176823b1-a331-44a1-8344-87a8ff7a8f9a
Type
PLASMA DERIVATIVE
Nonproprietary name
Albumin Human
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Takeda Pharmaceuticals America, Inc.
Application
BLA101452
Marketing category
BLA
Marketing start
2002-08-09
Substance
ALBUMIN HUMAN
Active strength
.25 g/mL
Pharmacologic classes
Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FLEXBUMIN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUMIN HUMAN.25 g/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741380albumin human 25 % in 100 ML InjectionPSNbdb4e167-27a2-4b50-b245-43df9cd535cb17
1741375albumin human 25 % in 50 ML InjectionPSNbdb4e167-27a2-4b50-b245-43df9cd535cb17
1742403FLEXBUMIN 25 % in 100 ML InjectionPSNbdb4e167-27a2-4b50-b245-43df9cd535cb17
1742401FLEXBUMIN 25 % in 50 ML InjectionPSNbdb4e167-27a2-4b50-b245-43df9cd535cb17
1742403100 ML albumin human, USP 250 MG/ML Injection [Flexbumin]SBDbdb4e167-27a2-4b50-b245-43df9cd535cb17
174240150 ML albumin human, USP 250 MG/ML Injection [Flexbumin]SBDbdb4e167-27a2-4b50-b245-43df9cd535cb17
1741380100 ML albumin human, USP 250 MG/ML InjectionSCDbdb4e167-27a2-4b50-b245-43df9cd535cb17
174137550 ML albumin human, USP 250 MG/ML InjectionSCDbdb4e167-27a2-4b50-b245-43df9cd535cb17
1741375albumin human 12.5 GM per 50 ML InjectionSYbdb4e167-27a2-4b50-b245-43df9cd535cb17
1741380albumin human 25 % per 100 ML InjectionSYbdb4e167-27a2-4b50-b245-43df9cd535cb17
1741375albumin human 25 % per 50 ML InjectionSYbdb4e167-27a2-4b50-b245-43df9cd535cb17
1741380albumin human 25 GM per 100 ML InjectionSYbdb4e167-27a2-4b50-b245-43df9cd535cb17
1742401Flexbumin 12.5 GM per 50 ML InjectionSYbdb4e167-27a2-4b50-b245-43df9cd535cb17
1742403Flexbumin 25 % per 100 ML InjectionSYbdb4e167-27a2-4b50-b245-43df9cd535cb17
1742401Flexbumin 25 % per 50 ML InjectionSYbdb4e167-27a2-4b50-b245-43df9cd535cb17
1742403Flexbumin 25 GM per 100 ML InjectionSYbdb4e167-27a2-4b50-b245-43df9cd535cb17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0944-0493-010094404930112 BAG in 1 CARTON (0944-0493-01) / 50 mL in 1 BAG (0944-0493-03) 12 bag2002-08-090000-00-00NoNoCurrent
0944-0493-02009440493026 BAG in 1 CARTON (0944-0493-02) / 100 mL in 1 BAG (0944-0493-04) 6 bag2002-08-090000-00-00NoNoCurrent
0944-0493-030094404930350 mL in 1 BAG50 mlHistorical
0944-0493-0400944049304100 mL in 1 BAG100 mlHistorical