ERWINASE

Product NDC: 81561-413
11-digit product format: 815610413
Labeler code: 81561
Product ID: 81561-413_10bba7af-957c-4cc6-ba44-5569fca4f885
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: asparaginase
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAMUSCULAR; INTRAVENOUS
Labeler: Porton Biopharma Limited
Marketing category: UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE
Marketing start: 2021-06-01
Marketing end: 0000-00-00
Substance: ASPARAGINASE ERWINIA CHRYSANTHEMI
Active strength: 10000 [iU]/mL
Pharmacologic classes: Asparaginase [CS],Asparagine-specific Enzyme [EPC]
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	81561-413		I	Inactivated by FDA		2026-08-17
excluded package	package	81561-413	81561-413-05	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	81561-413-05	`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	81561-413-05	`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	81561-413-05	`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	81561-413-05	`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	81561-413-05	`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	81561-413-05	`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	81561-413-05	`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	81561-413-05	`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	81561-413-05	`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	81561-413-05	`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	81561-413-05	`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	81561-413-05	`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	81561-413-05	`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	81561-413-05	`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	81561-413-05	`1332a3947898…`	`d4bfe170f9cd…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cb89b86a-369e-4204-8910-ae797c503af3	Product name	1	20230706
ecb42c05-a297-4ddf-bbd1-f324912e7232	Product name	1	20220125
d4880ace-a516-8c47-8dfd-73a4ba5887d7	Product name	2	20180830
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81561-413-05	2023-01-30	C162847	48780-1	f386c649-e889-0266-e053-dadaa90a7c1a	bd0f5322-a1d3-79c3-e053-2995a90acd70

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81561-413-01	ERWINASE	1 mL in 1 VIAL, GLASS	INJECTION, POWDER, LYOPHILIZED,	1		2
81561-413-05	ERWINASE	5 in 1 CARTON	INJECTION, POWDER, LYOPHILIZED,	5		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81561-413-05	EA - Each	81561-413	6f807cd8-3407-4e3e-9f82-e7da172c9dc9	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81561-413	ERWINASE (ASPARAGINASE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PORTON BIOPHARMA LIMITED]	2	Legacy NDC, 2 package rows	20210616_bd0f5322-a1d3-79c3-e053-2995a90acd70.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
150889	asparaginase Erwinia chrysanthemi 10,000 UNT Injection	PSN	bd0f5322-a1d3-79c3-e053-2995a90acd70	2
1232190	Erwinaze 10,000 UNT Injection	PSN	bd0f5322-a1d3-79c3-e053-2995a90acd70	2
1232190	asparaginase Erwinia chrysanthemi 10000 UNT Injection [Erwinaze]	SBD	bd0f5322-a1d3-79c3-e053-2995a90acd70	2
150889	asparaginase Erwinia chrysanthemi 10000 UNT Injection	SCD	bd0f5322-a1d3-79c3-e053-2995a90acd70	2
150889	asparaginase Erwinia chrysanthemi (as crisantaspase) 10000 UNT Injection	SY	bd0f5322-a1d3-79c3-e053-2995a90acd70	2
1232190	Erwinaze 10,000 UNT Injection	SY	bd0f5322-a1d3-79c3-e053-2995a90acd70	2
1232190	Erwinaze 10000 UNT Injection	SY	bd0f5322-a1d3-79c3-e053-2995a90acd70	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81561-413-01	81561041301	1 mL in 1 VIAL, GLASS	1 ml					Historical
81561-413-05	81561041305	5 VIAL, GLASS in 1 CARTON (81561-413-05) > 1 mL in 1 VIAL, GLASS (81561-413-01)		2021-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ERWINASE - Porton Biopharma Limited	Porton Biopharma Limited	2021-06-15	HUMAN PRESCRIPTION DRUG LABEL	2