FDA.reportPublic FDA data

Albumin (Human)

Product NDC
68982-643
11-digit product format
689820643
Labeler code
68982
Product ID
68982-643_a7f20f1e-404c-4c20-9cf6-e0f6074aa531
Type
PLASMA DERIVATIVE
Nonproprietary name
Albumin Human
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Octapharma USA Inc
Application
BLA125154
Marketing category
BLA
Marketing start
2006-10-17
Substance
ALBUMIN HUMAN
Active strength
250 g/1000mL
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
Albumin (Human)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALBUMIN HUMAN250 g/1000mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68982-643-01Albumin (Human)50 mL in 1 BOTTLE, GLASSSOLUTION506
68982-643-02Albumin (Human)100 mL in 1 BOTTLE, GLASSSOLUTION1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68982-643-01ML - Milliliter68982-643d538b1d9-f961-415c-91e7-ecf74704938b12015-09-10
68982-643-02ML - Milliliter68982-643df23c2a6-ff7b-48af-9b11-c6073abd37c012015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUMIN (HUMAN)ACTIVE INGREDIENTZIF514RVZRALBUMIN (HUMAN) (ALBUMIN HUMAN) SOLUTION [OCTAPHARMA USA INC]1
ALBUMIN (HUMAN)ACTIVE MOIETYZIF514RVZRALBUMIN (HUMAN) (ALBUMIN HUMAN) SOLUTION [OCTAPHARMA USA INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68982-643BEIZRAY (DOCETAXEL) KIT [ZHUHAI BEIHAI BIOTECH CO., LTD.]7Current NDC, Legacy NDC20241106_3538b979-8cac-49ed-b8dc-50f73ce38c72.zip
68982-643ALBUMIN (HUMAN) (ALBUMIN HUMAN) SOLUTION [OCTAPHARMA USA INC]6Current NDC, Legacy NDC, 2 package rows20200408_07734008-9dd3-b006-0825-65147c58e1ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741380albumin human 25 % in 100 ML InjectionPSN07734008-9dd3-b006-0825-65147c58e1ac6
1741375albumin human 25 % in 50 ML InjectionPSN07734008-9dd3-b006-0825-65147c58e1ac6
1741380100 ML albumin human, USP 250 MG/ML InjectionSCD07734008-9dd3-b006-0825-65147c58e1ac6
174137550 ML albumin human, USP 250 MG/ML InjectionSCD07734008-9dd3-b006-0825-65147c58e1ac6
1741375albumin human 12.5 GM per 50 ML InjectionSY07734008-9dd3-b006-0825-65147c58e1ac6
1741380albumin human 25 % per 100 ML InjectionSY07734008-9dd3-b006-0825-65147c58e1ac6
1741375albumin human 25 % per 50 ML InjectionSY07734008-9dd3-b006-0825-65147c58e1ac6
1741380albumin human 25 GM per 100 ML InjectionSY07734008-9dd3-b006-0825-65147c58e1ac6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68982-643-016898206430150 mL in 1 BOTTLE, GLASS (68982-643-01) 50 ml2006-10-170000-00-00NoNoCurrent
68982-643-0268982064302100 mL in 1 BOTTLE, GLASS (68982-643-02) 100 ml2006-10-170000-00-00NoNoCurrent