FDA.reportPublic FDA data

AlphaNine

Product NDC
68516-3612
11-digit product format
685163612
Labeler code
68516
Product ID
68516-3612_8b01a6ae-2639-401f-9b03-45350a21e166
Type
PLASMA DERIVATIVE
Nonproprietary name
COAGULATION FACTOR IX (HUMAN)
Dosage form
KIT
Route
INTRAVENOUS
Labeler
GRIFOLS USA, LLC
Application
BLA103249
Marketing category
BLA
Marketing start
1990-12-31
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AlphaNine
Brand name suffix
SD
Listing expiration
2026-12-31

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac74f96-3910-44b9-8551-036880fbb1fbProduct name120260108
0a18eae4-4259-42db-86b6-915f66e83b06Product name120250729
2c999b01-2a13-4eff-8eb4-00b87316ef79Product name120231116
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68516-3606-2AlphaNine SD10 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,10 mL1500 [iU] in 10mL25
68516-3612-2AlphaNine SD1 in 1 CARTONKIT125
76297-002-12AlphaNine SD10 mL in 1 VIAL, GLASSSOLUTION10 mL1 mL in 1mL25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68516-3612-2EA - Each68516-3612236bc97c-78dc-4556-823c-bc732c76e49f12022-02-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COAGULATION FACTOR IX HUMANACTIVE INGREDIENT6U90Y1795TALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10
Coagulation Factor IX HumanACTIVE MOIETY6U90Y1795TALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10
dextroseINACTIVE INGREDIENTIY9XDZ35W2ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10
heparinINACTIVE INGREDIENTT2410KM04AALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10
sodium chlorideINACTIVE INGREDIENT451W47IQ8XALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68516-3612ALPHANINE SD (COAGULATION FACTOR IX (HUMAN)) KIT [GRIFOLS USA, LLC]24Current NDC, Legacy NDC, 3 package rows20240123_3e99052d-4442-4283-8915-c9a796c77008.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666309AlphaNine SD 1 UNT InjectionPSN3e99052d-4442-4283-8915-c9a796c7700825
1666303factor IX, human 1 UNT InjectionPSN3e99052d-4442-4283-8915-c9a796c7700825
1666309coagulation factor IX, human 1 UNT Injection [Alphanine SD]SBD3e99052d-4442-4283-8915-c9a796c7700825
1666303coagulation factor IX, human 1 UNT InjectionSCD3e99052d-4442-4283-8915-c9a796c7700825
1666309Alphanine SD 1 UNT InjectionSY3e99052d-4442-4283-8915-c9a796c7700825

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68516-3606-26851636060210 mL in 1 VIAL10 mlHistorical
68516-3612-2685163612021 KIT in 1 CARTON (68516-3612-2) * 10 mL in 1 VIAL (68516-3606-2) * 10 mL in 1 VIAL, GLASS (76297-002-12) 1 kit1990-12-310000-00-00NoNoCurrent
76297-002-127629700021210 mL in 1 VIAL, GLASS10 mlHistorical