FDA.reportPublic FDA data

AlphaNine

Product NDC
68516-3603
11-digit product format
685163603
Labeler code
68516
Product ID
68516-3603_3d092e6a-6ace-47a6-84fd-0fcf676a0553
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
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68516-3603DDiscontinued by firm2026-08-03
excluded packagepackage68516-360368516-3603-2DDiscontinued by firm2026-08-03

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68516-3603-2EA - Each68516-360315df02c5-1da6-4e41-8e88-c9d07c8931e312012-07-24

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
103249Alphanine, Alphanine Hp, Alphanine SdCoagulation Factor IX (Human)351(a)Rx2026-06-01