Adagen

Product NDC: 57665-001
11-digit product format: 576650001
Labeler code: 57665
Product ID: 57665-001_b0affb48-ca3f-46a7-8260-5a4819eb21d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pegademase bovine
Dosage form: INJECTION, SOLUTION
Route: INTRAMUSCULAR
Labeler: Leadiant Biosciences, Inc.
Application: NDA019818
Marketing category: NDA
Marketing start: 2010-10-18
Marketing end: 0000-00-00
Substance: PEGADEMASE BOVINE
Active strength: 250 [iU]/mL
Pharmacologic classes: Adenosine Deaminase [CS],Bovine Intestinal Adenosine Deaminase [EPC]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	57665-001		D	Discontinued by firm		2026-07-31
excluded package	package	57665-001	57665-001-01	D	Discontinued by firm		2026-07-31

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57665-001-01	ML - Milliliter	57665-001	8aad1695-c2e1-434f-827e-c9de61ae48de	1	2012-07-24

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PEGADEMASE BOVINE	ACTIVE INGREDIENT	HW3H7D91F6	ADAGEN (PEGADEMASE BOVINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	7
PEGADEMASE BOVINE	ACTIVE MOIETY	HW3H7D91F6	ADAGEN (PEGADEMASE BOVINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	7
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ADAGEN (PEGADEMASE BOVINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	7
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	ADAGEN (PEGADEMASE BOVINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	7
SODIUM PHOSPHATE, MONOBASIC	INACTIVE INGREDIENT	3980JIH2SW	ADAGEN (PEGADEMASE BOVINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	ADAGEN (PEGADEMASE BOVINE) INJECTION, SOLUTION [SIGMA-TAU PHARMACEUTICALS, INC.]	7

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
HW3H7D91F6	PEGADEMASE BOVINE	PEGADEMASE BOVINE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ADAGEN ® (pegademase bovine) Injection	Leadiant Biosciences, Inc.	2019-06-26	HUMAN PRESCRIPTION DRUG LABEL	11