Ixinity

Product NDC: 70504-0288
11-digit product format: 705040288
Labeler code: 70504
Product ID: 70504-0288_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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70504-0288		I	Inactivated by FDA		2026-08-17
excluded package	package	70504-0288	70504-0288-5	I	Inactivated by FDA		2026-08-17

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70504-0288-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70504-0288-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70504-0288-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70504-0288-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70504-0288-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70504-0288-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70504-0288-5	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70504-0288-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70504-0288-5	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70504-0288-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70504-0288-5	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70504-0288-5	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	70504-0288-5	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	70504-0288-5	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	70504-0288-5	`1332a3947898…`	`d4bfe170f9cd…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70504-0288-5	2023-01-30	C162847	48780-1	f386c649-9b72-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use IXINITY® safely and effectively. See full prescribing information for IXINITY.. IXINITY [coagulation factor IX (recombinant)] Lyophilized Powder for Solution for Intravenous Injection Initial U.S. Approval: 2015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70504-0276-1	Ixinity	5 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	5 mL	2000 [iU] in 5mL	10
70504-0288-5	Ixinity	1 in 1 CARTON	KIT	1		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70504-0288-5	EA - Each	70504-0288	e1b9614c-1092-4ab6-86b8-eae781594782	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70504-0288	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#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1666311	coagulation factor IX (recombinant human) 1 UNT Injection	PSN	9521898c-61aa-44ab-8ab8-84274ca19943	10
1666328	IXINITY 1 UNT Injection	PSN	9521898c-61aa-44ab-8ab8-84274ca19943	10
1666328	nonacog alfa 1 UNT Injection [Ixinity]	SBD	9521898c-61aa-44ab-8ab8-84274ca19943	10
1666311	nonacog alfa 1 UNT Injection	SCD	9521898c-61aa-44ab-8ab8-84274ca19943	10
1666328	Ixinity (coagulation factor IX (recombinant human)) 1 UNT Injection	SY	9521898c-61aa-44ab-8ab8-84274ca19943	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70504-0276-1	70504027601	5 mL in 1 VIAL	5 ml					Historical
70504-0288-5	70504028805	1 KIT in 1 CARTON (70504-0288-5) * 5 mL in 1 VIAL (70504-0276-1) * 5 mL in 1 SYRINGE (70504-0280-1)	1 kit	2017-05-12	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Ixinity - Aptevo BioTherapeutics LLC	Aptevo BioTherapeutics LLC	2021-02-23	HUMAN PRESCRIPTION DRUG LABEL	10