FDA.reportPublic FDA data

Albumin (Human)

Product NDC
67467-623
11-digit product format
674670623
Labeler code
67467
Product ID
67467-623_0115cedc-4781-0619-f8c9-82e8199df443
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
50 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
67467-623-012019-10-21C16284748780-1956f9ecf-d32c-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use ALBUMIN (HUMAN) 5% safely and effectively. See full prescribing information for ALBUMIN (HUMAN) 5%. ALBUMIN (HUMAN) 5% For intravenous use only 5% solution Initial U.S. Approval: 2006
67467-623-022019-10-21C16284748780-1956f9ecf-d32c-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use ALBUMIN (HUMAN) 5% safely and effectively. See full prescribing information for ALBUMIN (HUMAN) 5%. ALBUMIN (HUMAN) 5% For intravenous use only 5% solution Initial U.S. Approval: 2006
67467-623-032019-10-21C16284748780-1956f9ecf-d32c-621f-e053-dbdaa90a74adThese highlights do not include all the information needed to use ALBUMIN (HUMAN) 5% safely and effectively. See full prescribing information for ALBUMIN (HUMAN) 5%. ALBUMIN (HUMAN) 5% For intravenous use only 5% solution Initial U.S. Approval: 2006

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67467-623-01Albumin (Human)100 mL in 1 BOTTLE, GLASSSOLUTION1004
67467-623-02Albumin (Human)250 mL in 1 BOTTLE, GLASSSOLUTION2504
67467-623-03Albumin (Human)500 mL in 1 BOTTLE, GLASSSOLUTION5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67467-623-01ML - Milliliter67467-6239d294c3d-9b6e-4837-94e0-c553eed2657512012-07-24
67467-623-02ML - Milliliter67467-6239b435d04-02ca-475a-8a12-7916ca13147112012-07-24
67467-623-03ML - Milliliter67467-6234d8f9911-2c6d-46ad-8711-e9dc943880ae12012-07-24

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
67467-623ALBUMIN (HUMAN) (ALBUMIN HUMAN) SOLUTION [OCTAPHARMA PHARMAZEUTIKA PRODUKTIONSGESELLSCHAFT M.B.H.]4Legacy NDC, 3 package rows20100716_a912d27c-00cb-2ed0-effe-2d88d1f2ca67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1741410albumin human 5 % in 100 ML InjectionPSNa912d27c-00cb-2ed0-effe-2d88d1f2ca674
1741420albumin human 5 % in 250 ML InjectionPSNa912d27c-00cb-2ed0-effe-2d88d1f2ca674
1741423albumin human 5 % in 500 ML InjectionPSNa912d27c-00cb-2ed0-effe-2d88d1f2ca674
1741410100 ML albumin human, USP 50 MG/ML InjectionSCDa912d27c-00cb-2ed0-effe-2d88d1f2ca674
1741420250 ML albumin human, USP 50 MG/ML InjectionSCDa912d27c-00cb-2ed0-effe-2d88d1f2ca674
1741423500 ML albumin human, USP 50 MG/ML InjectionSCDa912d27c-00cb-2ed0-effe-2d88d1f2ca674
1741420albumin human 12.5 GM per 250 ML InjectionSYa912d27c-00cb-2ed0-effe-2d88d1f2ca674
1741423albumin human 25 GM per 500 ML InjectionSYa912d27c-00cb-2ed0-effe-2d88d1f2ca674
1741410albumin human 5 % per 100 ML InjectionSYa912d27c-00cb-2ed0-effe-2d88d1f2ca674
1741420albumin human 5 % per 250 ML InjectionSYa912d27c-00cb-2ed0-effe-2d88d1f2ca674
1741423albumin human 5 % per 500 ML InjectionSYa912d27c-00cb-2ed0-effe-2d88d1f2ca674
1741410albumin human 5 GM per 100 ML InjectionSYa912d27c-00cb-2ed0-effe-2d88d1f2ca674

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
67467-623-0167467062301100 mL in 1 BOTTLE, GLASS100 mlHistorical
67467-623-0267467062302250 mL in 1 BOTTLE, GLASS250 mlHistorical
67467-623-0367467062303500 mL in 1 BOTTLE, GLASS500 mlHistorical