ERWINAZE

Product NDC: 57902-249
11-digit product format: 579020249
Labeler code: 57902
Product ID: 57902-249_b5245dc8-c827-425b-b55e-e12673e70e7c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Asparaginase
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Jazz Pharmaceuticals, Inc.
Application: BLA125359
Marketing category: BLA
Marketing start: 2011-11-18
Marketing end: 2021-07-23
Substance: ASPARAGINASE ERWINIA CHRYSANTHEMI
Active strength: 10000 [iU]/mL
Pharmacologic classes: Asparaginase [CS],Asparagine-specific Enzyme [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	57902-249		D	Discontinued by firm		2026-08-17
excluded package	package	57902-249	57902-249-05	D	Discontinued by firm		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 · 24 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	57902-249-05	`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	57902-249-05	`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	57902-249-05	`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	57902-249-05	`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	57902-249-05	`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	57902-249-05	`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	57902-249-05	`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	57902-249-05	`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	57902-249-05	`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	57902-249-05	`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	57902-249-05	`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	57902-249-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2020-10-13	These highlights do not include all the information needed to use ERWINAZE ® safely and effectively. See full prescribing information for ERWINAZE. ERWINAZE (asparaginase Erwinia chrysanthemi ) for injection, for intramuscular or intravenous use Initial U.S. Approval: 2011
2020-09-27	These highlights do not include all the information needed to use ERWINAZE ® safely and effectively. See full prescribing information for ERWINAZE. ERWINAZE (asparaginase Erwinia chrysanthemi ) for injection, for intramuscular or intravenous use Initial U.S. Approval: 2011
2020-09-25	These highlights do not include all the information needed to use ERWINAZE ® safely and effectively. See full prescribing information for ERWINAZE. ERWINAZE (asparaginase Erwinia chrysanthemi ) for injection, for intramuscular or intravenous use Initial U.S. Approval: 2011
2020-07-22	These highlights do not include all the information needed to use ERWINAZE ® safely and effectively. See full prescribing information for ERWINAZE. ERWINAZE (asparaginase Erwinia chrysanthemi ) for injection, for intramuscular or intravenous use Initial U.S. Approval: 2011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57902-249-01	EA - Each	57902-249	ab7f6dce-573a-4659-81f2-fd7fd1ef9ac0	1	2012-07-24
57902-249-05	EA - Each	57902-249	693cd689-6618-4c9f-a91c-5d5deb61582d	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ASPARAGINASE ERWINIA CHRYSANTHEMI	ACTIVE INGREDIENT	D733ET3F9O	ERWINAZE (ASPARAGINASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JAZZ PHARMACEUTICALS, INC.]	13
ASPARAGINASE	ACTIVE MOIETY	G4FQ3CKY5R	ERWINAZE (ASPARAGINASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JAZZ PHARMACEUTICALS, INC.]	13
DEXTROSE MONOHYDRATE	INACTIVE INGREDIENT	LX22YL083G	ERWINAZE (ASPARAGINASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JAZZ PHARMACEUTICALS, INC.]	13
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ERWINAZE (ASPARAGINASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [JAZZ PHARMACEUTICALS, INC.]	13

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125359	Erwinaze	asparaginase Erwinia chrysanthemi	351(a)	Disc	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
D733ET3F9O	ASPARAGINASE ERWINIA CHRYSANTHEMI	1349719-22-7	ASPARAGINASE ERWINIA CHRYSANTHEMI
G4FQ3CKY5R	ASPARAGINASE	9015-68-3	Asparaginase

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
57902-249-05	57902024905	5 VIAL, GLASS in 1 CARTON (57902-249-05) > 1 mL in 1 VIAL, GLASS (57902-249-01)	2011-11-18	2021-07-23	No	No	Current