NDC 57902-249-01 - ERWINAZE

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 57902-249
Requested NDC: 57902-249-01
Package NDCs from labels: 57902-249-01, 57902-249-05
Manufacturer: Jazz Pharmaceuticals, Inc.
Effective date: 2020-06-28
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
ERWINAZE - Jazz Pharmaceuticals, Inc.	Jazz Pharmaceuticals, Inc.	2020-06-28	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

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

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 16 of 47 · 939 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dextrose in Lactated Ringers	DEXTROSE, SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	190da07e-a616-46e6-b4e5-1c0ba39306e5	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: LX22YL083G
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE	B. Braun Medical Inc.	f6d82772-638c-4584-b9d3-8833669f5963	2025-11-05	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Com-Pare2 Dual Yeast Relief Plus Multi-symptom Formula	CANDIDA ALBICANS, WOOD CREOSOTE, SODIUM CHLORIDE, SULPHUR	TRP Company	42b6b9b9-a673-0bba-e063-6394a90a8866	2025-11-03	Warnings	Exact identifier unii: 451W47IQ8X
Dextrose	DEXTROSE MONOHYDRATE	ICU Medical, Inc.	8b25b7e0-703e-4b43-a4eb-52863511602d	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: LX22YL083G
Potassium Chloride in Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, AND POTASSIUM CHLORIDE	ICU Medical Inc.	d8ee14e9-6733-4813-9f21-2b043a5f7188	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: LX22YL083G
Dextrose and Sodium Chloride	DEXTROSE MONOHYDRATE AND SODIUM CHLORIDE	ICU Medical Inc.	4555b1bf-6d97-4798-a63d-6d34291c85ce	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: LX22YL083G
Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	ICU Medical Inc.	9dd1c001-73b3-41d4-9a96-61f6ad3a5dc3	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Dextrose	DEXTROSE	ICU Medical Inc.	b5cb7a5a-bbe8-4217-a82e-da818f7771c9	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: LX22YL083G
Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	3cfdeee0-ff14-4341-8396-b11c2a037c60	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	5f372b75-d7a4-471e-8ac6-290040fc84b0	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Sodium Chloride	SODIUM CHLORIDE AND POTASSIUM CHLORIDE	ICU Medical Inc.	243fe8fc-996a-4855-8daf-069628e547c4	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Lactated Ringers and Dextrose	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, AND DEXTROSE MONOHYDRATE	ICU Medical Inc.	d310d170-5eeb-471b-af1a-0e845001d21d	2025-11-02	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: LX22YL083G
Dextrose	DEXTROSE MONOHYDRATE	ICU Medical, Inc.	cb578dba-094c-4787-951d-763d12fd06e1	2025-11-01	Warnings, Adverse reactions	Exact identifier unii: LX22YL083G
Family Care Saline	SODIUM CHLORIDE	United Exchange Corp.	06737393-d4ae-3e7b-e063-6394a90ac19f	2025-10-31	Warnings	Exact identifier unii: 451W47IQ8X
Sodium Chloride	SODIUM CHLORIDE	ICU Medical Inc.	009bef3c-e8ac-46be-b564-a2556adf0081	2025-10-31	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Lactated Ringers and Dextrose	POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM LACTATE, AND DEXTROSE MONOHYDRATE	ICU Medical Inc.	237b39fa-916e-4a54-99c8-4ae9ad54f056	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: LX22YL083G
Normosol-R and Dextrose	DEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	ICU Medical Inc.	ead1fca3-eff4-478f-8a8f-67510f80151a	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X unii: LX22YL083G
Normosol-R	SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE	ICU Medical Inc.	0e089a44-0cee-4804-8f6f-8508508ddb5c	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: 451W47IQ8X
Potassium Chloride in Dextrose	DEXTROSE MONOHYDRATE AND POTASSIUM CHLORIDE INJECTION, SOLUTION	ICU Medical Inc.	02d694b5-3600-4d55-bd5c-924abaec5315	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: LX22YL083G
Ionosol MB and Dextrose	DEXTROSE MONOHYDRATE, SODIUM LACTATE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM PHOSPHATE, MONOBASIC, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	ICU Medical Inc.	1b457b1d-0e80-4578-ba6f-dedf513fc962	2025-10-30	Warnings, Adverse reactions	Exact identifier unii: LX22YL083G

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.