FDA.reportPublic FDA data

Albumin (Human)

Product NDC
67467-643
11-digit product format
674670643
Labeler code
67467
Product ID
67467-643_be20e36e-0b6e-7b05-82ac-7078b2befd03
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Albumin Human
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Octapharma Pharmazeutika Produktionsgesellschaft m.b.H.
Application
BLA125154
Marketing category
BLA
Marketing start
2006-10-17
Marketing end
0000-00-00
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
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67467-643-012019-10-21C16284748780-1956f9ecf-d2a8-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use ALBUMIN (HUMAN) 25% safely and effectively. See full prescribing information for ALBUMIN (HUMAN) 25%. ALBUMIN (HUMAN) 25% For intravenous use only 25% solution Initial U.S. Approval: 2006
67467-643-022019-10-21C16284748780-1956f9ecf-d2a8-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use ALBUMIN (HUMAN) 25% safely and effectively. See full prescribing information for ALBUMIN (HUMAN) 25%. ALBUMIN (HUMAN) 25% For intravenous use only 25% solution Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67467-643-01Albumin (Human)50 mL in 1 BOTTLE, GLASSSOLUTION504
67467-643-02Albumin (Human)100 mL in 1 BOTTLE, GLASSSOLUTION1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67467-643-01ML - Milliliter67467-6435e9733f4-4fc3-45ed-9661-fc691ab823e412012-07-24
67467-643-02ML - Milliliter67467-64310d5e8a3-5305-4cab-8806-ac025127d6ac12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALBUMIN (HUMAN)ACTIVE INGREDIENTZIF514RVZRALBUMIN (HUMAN) (ALBUMIN HUMAN) SOLUTION [OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESELLSCHAFT M.B.H.]4
ALBUMIN (HUMAN)ACTIVE MOIETYZIF514RVZRALBUMIN (HUMAN) (ALBUMIN HUMAN) SOLUTION [OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESELLSCHAFT M.B.H.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67467-643ALBUMIN (HUMAN) (ALBUMIN HUMAN) SOLUTION [OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESELLSCHAFT M.B.H.]4Legacy NDC, 2 package rows20100723_4ddaae99-05e1-e05c-e63c-0c58965d157d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741380albumin human 25 % in 100 ML InjectionPSN4ddaae99-05e1-e05c-e63c-0c58965d157d4
1741375albumin human 25 % in 50 ML InjectionPSN4ddaae99-05e1-e05c-e63c-0c58965d157d4
1741380100 ML albumin human, USP 250 MG/ML InjectionSCD4ddaae99-05e1-e05c-e63c-0c58965d157d4
174137550 ML albumin human, USP 250 MG/ML InjectionSCD4ddaae99-05e1-e05c-e63c-0c58965d157d4
1741375albumin human 12.5 GM per 50 ML InjectionSY4ddaae99-05e1-e05c-e63c-0c58965d157d4
1741380albumin human 25 % per 100 ML InjectionSY4ddaae99-05e1-e05c-e63c-0c58965d157d4
1741375albumin human 25 % per 50 ML InjectionSY4ddaae99-05e1-e05c-e63c-0c58965d157d4
1741380albumin human 25 GM per 100 ML InjectionSY4ddaae99-05e1-e05c-e63c-0c58965d157d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67467-643-016746706430150 mL in 1 BOTTLE, GLASS50 mlHistorical
67467-643-0267467064302100 mL in 1 BOTTLE, GLASS100 mlHistorical