Octaplas

Product NDC
68982-955
11-digit product format
689820955
Labeler code
68982
Product ID
68982-955_b3e64112-a51b-c07f-8d10-0d204fa27a80
Type
PLASMA DERIVATIVE
Nonproprietary name
human plasma proteins
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Octapharma USA Inc
Application
BLA125416
Marketing category
BLA
Marketing start
2013-07-18
Substance
PLASMA PROTEIN FRACTION (HUMAN)
Active strength
11.5 g/200mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Octaplas
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PLASMA PROTEIN FRACTION (HUMAN)11.5 g/200mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68982-955-01Octaplas200 mL in 1 BAGSOLUTION20025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68982-955-01ML - Milliliter68982-9557efd4385-1837-4cac-80cb-20fa060ec3fa12016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PLASMA PROTEIN FRACTION (HUMAN)ACTIVE INGREDIENT6D53G0FD0ZOCTAPLAS (HUMAN PLASMA PROTEINS) SOLUTION [OCTAPHARMA USA INC]4
PLASMA PROTEIN FRACTION (HUMAN)ACTIVE MOIETY6D53G0FD0ZOCTAPLAS (HUMAN PLASMA PROTEINS) SOLUTION [OCTAPHARMA USA INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68982-955OCTAPLAS (HUMAN PLASMA PROTEINS) SOLUTION [OCTAPHARMA USA INC]25Current NDC, Legacy NDC, 1 package rows20241022_e629b5ce-f4e8-59d7-5000-cc874da27d2a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68982-955-0168982095501200 mL in 1 BAG (68982-955-01) 200 ml2013-07-180000-00-00NoNoCurrent