Home NDC 57665-001 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 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 57665-001-01 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 57665-001-01 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 57665-001-01 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 57665-001-01 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 57665-001-01 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 57665-001-01 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 57665-001-01 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 57665-001-01 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 57665-001-01 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 57665-001-01 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 57665-001-01 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 57665-001-01 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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