FDA.reportPublic FDA data

ALBURX

Product NDC
44206-310
11-digit product format
442060310
Labeler code
44206
Product ID
44206-310_570bfd23-8f64-45f1-9ad4-c07a6e310c12
Type
PLASMA DERIVATIVE
Nonproprietary name
ALBUMIN (HUMAN)
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
CSL Behring AG
Application
BLA102366
Marketing category
BLA
Marketing start
2009-01-06
Substance
ALBUMIN HUMAN
Active strength
12.5 g/250mL
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct44206-310DDiscontinued by firm2026-08-10
excluded packagepackage44206-31044206-310-11DDiscontinued by firm2026-08-10

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage44206-310-11d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage44206-310-11f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage44206-310-112ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage44206-310-11a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage44206-310-11cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage44206-310-11cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage44206-310-11302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage44206-310-11ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage44206-310-110efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage44206-310-11ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage44206-310-11367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage44206-310-11557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
ALBURX
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUMIN HUMAN12.5 g/250mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
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
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct 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
44206-310-25ALBURX1 in 1 CARTONSOLUTION110
44206-310-50ALBURX1 in 1 CARTONSOLUTION110
44206-310-90ALBURX250 mL in 1 VIAL, GLASSSOLUTION25010
44206-310-91ALBURX500 mL in 1 VIAL, GLASSSOLUTION50010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44206-310-25ML - Milliliter44206-310a69019b8-5707-4228-aff4-3ee17976191112012-07-24
44206-310-50ML - Milliliter44206-310cfd7278e-e1b9-433a-b654-62a8b5f7c88912012-07-24
44206-310-90ML - Milliliter44206-310151a8b60-b52f-40e4-9d2f-bab93b0f4a0512017-03-06
44206-310-91ML - Milliliter44206-310420027b7-8874-4881-a1fa-2e3c5a5c397412017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUMIN HUMANACTIVE INGREDIENTZIF514RVZRALBURX (ALBUMIN (HUMAN)) SOLUTION [CSL BEHRING AG]6
ALBUMIN HUMANACTIVE MOIETYZIF514RVZRALBURX (ALBUMIN (HUMAN)) SOLUTION [CSL BEHRING AG]6
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10ALBURX (ALBUMIN (HUMAN)) SOLUTION [CSL BEHRING AG]6
SODIUM ACETYLTRYPTOPHANATEINACTIVE INGREDIENT3EN9H0M2FXALBURX (ALBUMIN (HUMAN)) SOLUTION [CSL BEHRING AG]6
SODIUM CAPRYLATEINACTIVE INGREDIENT9XTM81VK2BALBURX (ALBUMIN (HUMAN)) SOLUTION [CSL BEHRING AG]6
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XALBURX (ALBUMIN (HUMAN)) SOLUTION [CSL BEHRING AG]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44206-310ALBURX (ALBUMIN (HUMAN)) SOLUTION [CSL BEHRING AG]10Current NDC, Legacy NDC, 4 package rows20220811_56a6ad30-153d-4adf-9d92-a82ec19fa1b8.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
102366AlburxAlbumin (Human)351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741420albumin human 5 % in 250 ML InjectionPSN56a6ad30-153d-4adf-9d92-a82ec19fa1b810
1741423albumin human 5 % in 500 ML InjectionPSN56a6ad30-153d-4adf-9d92-a82ec19fa1b810
1741899AlbuRx 5 % in 250 ML InjectionPSN56a6ad30-153d-4adf-9d92-a82ec19fa1b810
1741903AlbuRx 5 % in 500 ML InjectionPSN56a6ad30-153d-4adf-9d92-a82ec19fa1b810
1741899250 ML albumin human, USP 50 MG/ML Injection [Alburx]SBD56a6ad30-153d-4adf-9d92-a82ec19fa1b810
1741903500 ML albumin human, USP 50 MG/ML Injection [Alburx]SBD56a6ad30-153d-4adf-9d92-a82ec19fa1b810
1741420250 ML albumin human, USP 50 MG/ML InjectionSCD56a6ad30-153d-4adf-9d92-a82ec19fa1b810
1741423500 ML albumin human, USP 50 MG/ML InjectionSCD56a6ad30-153d-4adf-9d92-a82ec19fa1b810
1741420albumin human 12.5 GM per 250 ML InjectionSY56a6ad30-153d-4adf-9d92-a82ec19fa1b810
1741423albumin human 25 GM per 500 ML InjectionSY56a6ad30-153d-4adf-9d92-a82ec19fa1b810
1741420albumin human 5 % per 250 ML InjectionSY56a6ad30-153d-4adf-9d92-a82ec19fa1b810
1741423albumin human 5 % per 500 ML InjectionSY56a6ad30-153d-4adf-9d92-a82ec19fa1b810
1741899AlbuRx 12.5 GM per 250 ML InjectionSY56a6ad30-153d-4adf-9d92-a82ec19fa1b810
1741903Alburx 25 GM per 500 ML InjectionSY56a6ad30-153d-4adf-9d92-a82ec19fa1b810
1741899AlbuRx 5 % per 250 ML InjectionSY56a6ad30-153d-4adf-9d92-a82ec19fa1b810
1741903Alburx 5 % per 500 ML InjectionSY56a6ad30-153d-4adf-9d92-a82ec19fa1b810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44206-310-25442060310251 VIAL, GLASS in 1 CARTON (44206-310-25) / 250 mL in 1 VIAL, GLASS (44206-310-90) 2009-01-060000-00-00NoNoCurrent
44206-310-50442060310501 VIAL, GLASS in 1 CARTON (44206-310-50) / 500 mL in 1 VIAL, GLASS (44206-310-91) 2009-01-060000-00-00NoNoCurrent
44206-310-9044206031090250 mL in 1 VIAL, GLASS250 mlHistorical
44206-310-9144206031091500 mL in 1 VIAL, GLASS500 mlHistorical