FDA.reportPublic FDA data

ADYNOVATE

Product NDC
0944-4258
11-digit product format
009444258
Labeler code
0944
Product ID
0944-4258_d8242f09-2cc1-4d6b-ab8b-5fe19ba8dd0a
Type
PLASMA DERIVATIVE
Nonproprietary name
antihemophilic factor (recombinant) pegylated
Dosage form
KIT
Labeler
BAXALTA US INC.
Application
BLA125566
Marketing category
BLA
Marketing start
2015-11-13
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct0944-4258DDiscontinued by firm2026-07-31
excluded packagepackage0944-42580944-4258-02DDiscontinued by firm2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0944-4258-022020-04-03C16284748780-19d75b9d0-51e2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ADYNOVATE safely and effectively. See full prescribing information for ADYNOVATE. ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated Lyophilized Powder for Solution For Intravenous Injection. Initial U.S. Approval: 2015
0944-4258-022020-01-31C16284748780-19d75b9d0-51e2-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ADYNOVATE safely and effectively. See full prescribing information for ADYNOVATE. ADYNOVATE, Antihemophilic Factor (Recombinant), PEGylated Lyophilized Powder for Solution For Intravenous Injection. Initial U.S. Approval: 2015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0944-4258-02EA - Each0944-4258513a2461-0dd8-49b4-895c-7454654d5e5412016-01-13

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125566AdynovateAntihemophilic Factor (Recombinant), PEGylated351(a)Rx2026-06-01