FDA.reportPublic FDA data

Alphanate

Product NDC
68516-4615
11-digit product format
685164615
Labeler code
68516
Product ID
68516-4615_7be024b3-03db-4aab-b46d-2fedb2071f23
Type
PLASMA DERIVATIVE
Nonproprietary name
Antihemophilic Factor/von Willebrand Factor Complex (Human)
Dosage form
KIT
Route
INTRAVENOUS
Labeler
GRIFOLS USA, LLC
Application
BLA102475
Marketing category
BLA
Marketing start
2014-06-26
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Alphanate
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
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68516-1002-2Alphanate10 mL in 1 VIAL, SINGLE-DOSEINJECTION10 mL1 mL in 1mL26
68516-4610-2Alphanate10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,10 mL2000 [iU] in 10mL26
68516-4615-2Alphanate1 in 1 CARTONKIT126

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68516-4615-2EA - Each68516-46158cf1d020-2bf6-4ba6-95a6-a807302c853512018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEXACTIVE INGREDIENT5T6B772R4QALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]12
HUMAN COAGULATION FACTOR VIII/VON WILLEBRAND FACTOR COMPLEXACTIVE MOIETY5T6B772R4QALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]12
albumin (human)INACTIVE INGREDIENTZIF514RVZRALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]12
arginineINACTIVE INGREDIENT94ZLA3W45FALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]12
histidineINACTIVE INGREDIENT4QD397987EALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68516-4615ALPHANATE (ANTIHEMOPHILIC FACTOR/VON WILLEBRAND FACTOR COMPLEX (HUMAN)) KIT [GRIFOLS USA, LLC]25Current NDC, Legacy NDC, 3 package rows20231009_5a7aea94-654c-4113-9014-c3137de0a931.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1661345Alphanate (expressed as von Willebrand factor) 1 UNT InjectionPSN5a7aea94-654c-4113-9014-c3137de0a93126
1661332antihemophilic factor / von Willebrand factor complex, human 1 UNT InjectionPSN5a7aea94-654c-4113-9014-c3137de0a93126
1661345factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT Injection [Alphanate]SBD5a7aea94-654c-4113-9014-c3137de0a93126
1661332factor VIII, human 1 UNT / von Willebrand factor, human 1 UNT InjectionSCD5a7aea94-654c-4113-9014-c3137de0a93126
1661345Alphanate (expressed as von Willebrand factor) 1 UNT InjectionSY5a7aea94-654c-4113-9014-c3137de0a93126
1661332factor VIII / von Willebrand Factor complex, human 1 UNT InjectionSY5a7aea94-654c-4113-9014-c3137de0a93126

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68516-1002-26851610020210 mL in 1 VIAL, SINGLE-DOSE10 mlHistorical
68516-4610-26851646100210 mL in 1 VIAL10 mlHistorical
68516-4615-2685164615021 KIT in 1 CARTON (68516-4615-2) * 10 mL in 1 VIAL (68516-4610-2) * 10 mL in 1 VIAL, SINGLE-DOSE (68516-1002-2) 1 kit2014-06-260000-00-00NoNoCurrent