Krystexxa

Product NDC: 54396-801
11-digit product format: 543960801
Labeler code: 54396
Product ID: 54396-801_8ec18670-b429-432f-b7c5-7a43fd397c47
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pegloticase
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Savient Pharmaceuticals, Inc.
Application: BLA125293
Marketing category: BLA
Marketing start: 2010-09-14
Marketing end: 0000-00-00
Substance: PEGLOTICASE
Active strength: 8 mg/mL
Pharmacologic classes: Urate Oxidase [CS],Uric Acid-specific Enzyme [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	54396-801		I	Inactivated by FDA		2026-08-17
excluded package	package	54396-801	54396-801-01	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 · 44 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	54396-801-01	`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	54396-801-01	`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	54396-801-01	`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	54396-801-01	`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	54396-801-01	`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	54396-801-01	`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	54396-801-01	`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	54396-801-01	`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	54396-801-01	`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	54396-801-01	`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	54396-801-01	`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	54396-801-01	`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	54396-801-01	`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	54396-801-01	`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	54396-801-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54396-801-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54396-801-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54396-801-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54396-801-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54396-801-01	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54396-801-01	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	54396-801-01	`110d247fa046…`	`a55b01930146…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54396-801-01	2019-11-27	C162847	48780-1	9855d018-e6c3-cd31-e053-dbdaa90ab51a	These highlights do not include all the information needed to use KRYSTEXXA safely and effectively. See full prescribing information for KRYSTEXXA KRYSTEXXA ® (pegloticase) Injection, for intravenous infusion Initial U.S. Approval: 2010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54396-801-01	Krystexxa	1 in 1 CARTON	INJECTION, SOLUTION	1		5
54396-801-01	Krystexxa	1 mL in 1 VIAL	INJECTION, SOLUTION	1		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54396-801-01	ML - Milliliter	54396-801	b4ec210f-1e9a-4388-b828-8f935de186f5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PEGLOTICASE	ACTIVE INGREDIENT	R581OT55EA	KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [SAVIENT PHARMACEUTICALS, INC.]	5
PEGLOTICASE	ACTIVE MOIETY	R581OT55EA	KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [SAVIENT PHARMACEUTICALS, INC.]	5
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [SAVIENT PHARMACEUTICALS, INC.]	5
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	94255I6E2T	KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [SAVIENT PHARMACEUTICALS, INC.]	5
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE	INACTIVE INGREDIENT	5QWK665956	KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [SAVIENT PHARMACEUTICALS, INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [SAVIENT PHARMACEUTICALS, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54396-801	KRYSTEXXA (PEGLOTICASE) INJECTION, SOLUTION [SAVIENT PHARMACEUTICALS, INC.]	5	Legacy NDC, 2 package rows	20130419_5f4574d1-401f-4647-83e5-28c0f4a122a7.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
Krystexxa	PEGLOTICASE	Horizon Therapeutics USA, Inc.	6e566303-d93a-4130-b764-25749829aa95	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: BLA125293

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125293	Krystexxa	pegloticase	351(a)	Rx	2026-08-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R581OT55EA	PEGLOTICASE	885051-90-1	PEGLOTICASE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1011657	Krystexxa 8 MG in 1 ML Injection	PSN	5f4574d1-401f-4647-83e5-28c0f4a122a7	5
1011653	pegloticase 8 MG in 1 ML Injection	PSN	5f4574d1-401f-4647-83e5-28c0f4a122a7	5
1011657	1 ML pegloticase 8 MG/ML Injection [Krystexxa]	SBD	5f4574d1-401f-4647-83e5-28c0f4a122a7	5
1011653	1 ML pegloticase 8 MG/ML Injection	SCD	5f4574d1-401f-4647-83e5-28c0f4a122a7	5
1011657	Krystexxa (as uricase protein) 8 MG per 1 ML Injection	SY	5f4574d1-401f-4647-83e5-28c0f4a122a7	5
1011657	Krystexxa 8 MG per 1 ML Injection	SY	5f4574d1-401f-4647-83e5-28c0f4a122a7	5
1011653	pegloticase (as uricase protein) 8 MG per 1 ML Injection	SY	5f4574d1-401f-4647-83e5-28c0f4a122a7	5
1011653	pegloticase 8 MG per 1 ML Injection	SY	5f4574d1-401f-4647-83e5-28c0f4a122a7	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
54396-801-01	54396080101	1 in 1 CARTON	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Krystexxa	Savient Pharmaceuticals, Inc. \| Biotechnology General (Israel) Limited	2012-09-15	HUMAN PRESCRIPTION DRUG LABEL	5