Home NDC 70504-0282-5 Ixinity
Product NDC 70504-0282
Requested package NDC 70504-0282-5
11-digit product format 705040282
Labeler code 70504
Product ID 70504-0282_6f483b65-2f54-4dab-ab99-946eb6b6b418
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name coagulation factor IX (recombinant)
Dosage form KIT
Labeler Aptevo BioTherapeutics LLC
Application BLA125426
Marketing category BLA
Marketing start 2017-05-12
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 15 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70504-0270-1 Ixinity 5 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 5 mL 500 [iU] in 5mL 10 70504-0282-5 Ixinity 1 in 1 CARTON KIT 1 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70504-0282 IXINITY (COAGULATION FACTOR IX (RECOMBINANT)) KIT [APTEVO BIOTHERAPEUTICS LLC] 10 Legacy NDC, 2 package rows 20210305_9521898c-61aa-44ab-8ab8-84274ca19943.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ixinity COAGULATION FACTOR IX (RECOMBINANT) Medexus Pharma, Inc. 26bc221d-c9bc-4aba-92f3-6c21acaaf194 2024-04-03 Warnings, Adverse reactions Exact identifier application number: BLA125426
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125426 Ixinity Coagulation Factor IX (Recombinant) 351(a) Disc 2026-08-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70504-0282-5 70504028205 1 KIT in 1 CARTON (70504-0282-5) * 5 mL in 1 VIAL (70504-0270-1) * 5 mL in 1 SYRINGE (70504-0280-1) 1 kit 2017-05-12 0000-00-00 No No Current