FDA.reportPublic FDA data

ALBURX

Product NDC
44206-310
Requested package NDC
44206-310-25
11-digit product format
442060310
Labeler code
44206
Product ID
44206-310_76269907-bb6e-4724-bc94-88cb77674107
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ZIF514RVZRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1741420Internal RxNorm lookup
1741423Internal RxNorm lookup
1741899Internal RxNorm lookup
1741903Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
56a6ad30-153d-4adf-9d92-a82ec19fa1b8Available on FDA.report

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)Rx2026-10-01

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 formatDescriptionMarketing 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