Humate-P

Product NDC
63833-616
11-digit product format
638330616
Labeler code
63833
Product ID
63833-616_3fefdbbb-c86f-4ed6-b4f0-73bcad062e01
Type
PLASMA DERIVATIVE
Nonproprietary name
antihemophilic factor/von willebrand factor complex (human)
Dosage form
KIT
Labeler
CSL Behring GmbH
Application
BLA103960
Marketing category
BLA
Marketing start
1986-05-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63833-616-02Humate-P1 in 1 CARTONKIT116
63833-626-01Humate-P10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,10 mL80 [iU] in 1mL16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63833-616-02EA - Each63833-6166f66d773-6edb-459e-9d68-57c6a03cfbd012012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63833-616HUMATE-P (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [CSL BEHRING GMBH]16Current NDC, Legacy NDC, 2 package rows20200826_c5f4b63b-8d8b-45b3-b530-2f1c32a1b852.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661332antihemophilic factor / von Willebrand factor complex, human 1 UNT InjectionPSNc5f4b63b-8d8b-45b3-b530-2f1c32a1b85216
1661352Humate-P (expressed as von Willebrand factor) 1 UNT InjectionPSNc5f4b63b-8d8b-45b3-b530-2f1c32a1b85216
1661352factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT Injection [Humate-P]SBDc5f4b63b-8d8b-45b3-b530-2f1c32a1b85216
1661332factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT InjectionSCDc5f4b63b-8d8b-45b3-b530-2f1c32a1b85216
1661332factor VIII / von Willebrand Factor complex, human 1 UNT InjectionSYc5f4b63b-8d8b-45b3-b530-2f1c32a1b85216
1661352Humate-P (expressed as von Willebrand factor) 1 UNT InjectionSYc5f4b63b-8d8b-45b3-b530-2f1c32a1b85216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63833-616-02638330616021 KIT in 1 CARTON (63833-616-02) * 10 mL in 1 VIAL (63833-626-01) * 10 mL in 1 VIAL, SINGLE-DOSE (63833-765-54) 1 kit1986-05-010000-00-00NoNoCurrent
63833-626-016383306260110 mL in 1 VIAL10 mlHistorical