Ixinity

Product NDC: 59137-287
Requested package NDC: 59137-287-05
11-digit product format: 591370287
Labeler code: 59137
Product ID: 59137-287_5e2b1242-2977-463b-ac2c-f89dadfba407
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: coagulation factor IX (recombinant)
Dosage form: KIT
Labeler: Medexus Pharma, Inc.
Application: BLA125426
Marketing category: BLA
Marketing start: 2017-05-12
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	59137-287	59137-287-05	D	Discontinued by firm		2026-08-03

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 · 12 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…`

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1666311	Internal RxNorm lookup
1666328	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
26bc221d-c9bc-4aba-92f3-6c21acaaf194	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59137-275-01	Ixinity	5 mL in 1 VIAL	INJECTION, POWDER, LYOPHILIZED,	5 mL	250 [iU] in 5mL	8
59137-287-05	Ixinity	1 in 1 CARTON	KIT	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59137-287-05	EA - Each	59137-287	2aa145ea-069a-4061-afcf-4cd6d02737a5	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59137-287	IXINITY (COAGULATION FACTOR IX (RECOMBINANT)) KIT [MEDEXUS PHARMA, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20240405_26bc221d-c9bc-4aba-92f3-6c21acaaf194.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 ndc (package): 59137-287-05 ndc (product): 59137-287 ndc11 (package): 59137028705

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	2026-06-01

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	26bc221d-c9bc-4aba-92f3-6c21acaaf194	8
1666328	IXINITY 1 UNT Injection	PSN	26bc221d-c9bc-4aba-92f3-6c21acaaf194	8
1666328	nonacog alfa 1 UNT Injection [Ixinity]	SBD	26bc221d-c9bc-4aba-92f3-6c21acaaf194	8
1666311	nonacog alfa 1 UNT Injection	SCD	26bc221d-c9bc-4aba-92f3-6c21acaaf194	8
1666328	Ixinity (coagulation factor IX (recombinant human)) 1 UNT Injection	SY	26bc221d-c9bc-4aba-92f3-6c21acaaf194	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59137-287-05	59137028705	1 KIT in 1 CARTON (59137-287-05) * 5 mL in 1 VIAL (59137-275-01) * 5 mL in 1 SYRINGE (59137-280-01)	1 kit	2021-07-01	0000-00-00	No	No	Current