ALPROLIX

Product NDC
71104-933
11-digit product format
711040933
Labeler code
71104
Product ID
71104-933_24887518-9870-451a-9db5-b03dc5571c19
Type
PLASMA DERIVATIVE
Nonproprietary name
Coagulation Factor IX (Recombinant), Fc Fusion Protein
Dosage form
KIT
Labeler
Bioverativ Therapeutics Inc.
Application
BLA125444
Marketing category
BLA
Marketing start
2014-05-05
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71104-933-01ALPROLIX1 in 1 KITKIT112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71104-933-01EA - Each71104-9333cc79e5b-4793-46b5-ad6d-43323b0fb6e212018-08-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71104-933ALPROLIX (COAGULATION FACTOR IX (RECOMBINANT), FC FUSION PROTEIN) KIT [BIOVERATIV THERAPEUTICS INC.]12Current NDC, Legacy NDC, 1 package rows20240517_2fb3fb92-379d-4683-80d6-b06c0a7dc063.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1666323ALPROLIX 1 UNT InjectionPSN2fb3fb92-379d-4683-80d6-b06c0a7dc06312
1666320coagulation factor ix (recombinant), fc fusion protein 1 UNT InjectionPSN2fb3fb92-379d-4683-80d6-b06c0a7dc06312
1666323coagulation factor IX recombinant immunoglobulin G1 fusion protein 1 UNT Injection [Alprolix]SBD2fb3fb92-379d-4683-80d6-b06c0a7dc06312
1666320coagulation factor IX recombinant immunoglobulin G1 fusion protein 1 UNT InjectionSCD2fb3fb92-379d-4683-80d6-b06c0a7dc06312
1666323Alprolix 1 UNT InjectionSY2fb3fb92-379d-4683-80d6-b06c0a7dc06312

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71104-933-01711040933011 KIT in 1 KIT (71104-933-01) * 5 mL in 1 VIAL (71104-955-09) * 5 mL in 1 VIAL (71104-045-01) 1 kit2014-05-050000-00-00NoNoCurrent