FDA.reportPublic FDA data

ALBUMINEX

Product NDC
64208-2510
11-digit product format
642082510
Labeler code
64208
Product ID
64208-2510_7a994321-a724-4f00-a7e7-95dca159394f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albumin Human
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
BPL
Application
BLA125644
Marketing category
BLA
Marketing start
2020-05-27
Substance
ALBUMIN HUMAN
Active strength
.05 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
ALBUMINEX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUMIN HUMAN.05 g/mL

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
2054221Internal RxNorm lookup
2054223Internal RxNorm lookup
2054226Internal RxNorm lookup
2054227Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8428d373-f4b1-4e3b-bb19-ea89048f7c79Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64208-2510-1ALBUMINEX1 in 1 CARTONSOLUTION18
64208-2510-2ALBUMINEX250 mL in 1 VIAL, GLASSSOLUTION2508
64208-2510-5ALBUMINEX1 in 1 CARTONSOLUTION18
64208-2510-6ALBUMINEX500 mL in 1 VIAL, GLASSSOLUTION5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64208-2510-1ML - Milliliter64208-2510c817340a-bc73-4a0f-a637-e6d3d057a07012018-12-13
64208-2510-2ML - Milliliter64208-251069981ae2-6a04-48ac-82d5-5b763d8ddfc912019-06-19
64208-2510-5ML - Milliliter64208-251094cedc37-4d03-4eee-aed5-290ec19f52c612018-12-13
64208-2510-6ML - Milliliter64208-2510134336fb-9c27-46bd-a4aa-286375dc320512019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64208-2510ALBUMINEX (ALBUMIN HUMAN) SOLUTION [BPL]8Current NDC, Legacy NDC, 4 package rows20250109_8428d373-f4b1-4e3b-bb19-ea89048f7c79.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALBUMINEXALBUMIN HUMANBPL8428d373-f4b1-4e3b-bb19-ea89048f7c792024-12-31Warnings, Adverse reactionsExact identifier
application number: BLA125644
ndc (product): 64208-2510
ALBUMINEXALBUMIN HUMANBPL167f48d0-8ae5-4f7e-b050-9673dad78acc2024-12-31Warnings, Adverse reactionsExact identifier
application number: BLA125644

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125644AlbuminexAlbumin (Human)-kjda351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2054221albumin human-kjda 5 % in 250 ML InjectionPSN8428d373-f4b1-4e3b-bb19-ea89048f7c798
2054226albumin human-kjda 5 % in 500 ML InjectionPSN8428d373-f4b1-4e3b-bb19-ea89048f7c798
2054223ALBUMINEX 5 % in 250 ML InjectionPSN8428d373-f4b1-4e3b-bb19-ea89048f7c798
2054227ALBUMINEX 5 % in 500 ML InjectionPSN8428d373-f4b1-4e3b-bb19-ea89048f7c798
2054223250 ML albumin human-kjda 50 MG/ML Injection [Albuminex]SBD8428d373-f4b1-4e3b-bb19-ea89048f7c798
2054227500 ML albumin human-kjda 50 MG/ML Injection [Albuminex]SBD8428d373-f4b1-4e3b-bb19-ea89048f7c798
2054221250 ML albumin human-kjda 50 MG/ML InjectionSCD8428d373-f4b1-4e3b-bb19-ea89048f7c798
2054226500 ML albumin human-kjda 50 MG/ML InjectionSCD8428d373-f4b1-4e3b-bb19-ea89048f7c798
2054221albumin human-kjda 5 % per 250 ML InjectionSY8428d373-f4b1-4e3b-bb19-ea89048f7c798
2054226albumin human-kjda 5 % per 500 ML InjectionSY8428d373-f4b1-4e3b-bb19-ea89048f7c798
2054221albumin human-kjda 50 MG/ML per 250 ML InjectionSY8428d373-f4b1-4e3b-bb19-ea89048f7c798
2054226albumin human-kjda 50 MG/ML per 500 ML InjectionSY8428d373-f4b1-4e3b-bb19-ea89048f7c798
2054223Albuminex 5 % per 250 ML InjectionSY8428d373-f4b1-4e3b-bb19-ea89048f7c798
2054227Albuminex 5 % per 500 ML InjectionSY8428d373-f4b1-4e3b-bb19-ea89048f7c798
2054223Albuminex 50 MG/ML per 250 ML InjectionSY8428d373-f4b1-4e3b-bb19-ea89048f7c798
2054227Albuminex 50 MG/ML per 500 ML InjectionSY8428d373-f4b1-4e3b-bb19-ea89048f7c798

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64208-2510-1642082510011 VIAL, GLASS in 1 CARTON (64208-2510-1) / 250 mL in 1 VIAL, GLASS (64208-2510-2) 2020-05-270000-00-00NoNoCurrent
64208-2510-264208251002250 mL in 1 VIAL, GLASS250 mlHistorical
64208-2510-5642082510051 VIAL, GLASS in 1 CARTON (64208-2510-5) / 500 mL in 1 VIAL, GLASS (64208-2510-6) 2020-05-270000-00-00NoNoCurrent
64208-2510-664208251006500 mL in 1 VIAL, GLASS500 mlHistorical