Home NDC 57665-002 Revcovi
Product NDC 57665-002
11-digit product format 576650002
Labeler code 57665
Product ID 57665-002_35174065-15ec-4714-8c24-1feb7f715d22
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name elapegademase-lvlr
Dosage form INJECTION
Route INTRAMUSCULAR
Labeler Leadiant Biosciences, Inc.
Application BLA761092
Marketing category BLA
Marketing start 2018-10-05
Marketing end 2022-08-31
Substance ELAPEGADEMASE
Active strength 2 mg/mL
NDC exclude flag No
Listing certified through 0000-00-00
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 57665-002-01 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 57665-002-01 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 57665-002-01 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 57665-002-01 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 57665-002-01 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 57665-002-01 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 57665-002-01 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 57665-002-01 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 57665-002-01 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 57665-002-01 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 57665-002-01 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 57665-002-01 557ba5c1ecfa…9c80585c8c6e…
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57665-002-02 Oncaspar 1 in 1 CARTON INJECTION, SOLUTION 1 1 57665-002-02 Oncaspar 5 mL in 1 VIAL, SINGLE-USE INJECTION, SOLUTION 5 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded pegaspargase ACTIVE INGREDIENT 7D96IR0PPM ONCASPAR (PEGASPARGASE) INJECTION, SOLUTION FOR INTRAMUSCULAR AND INTRAVENOUS USE [ENZON PHARMACEUTICALS, INC.] 1 pegaspargase ACTIVE MOIETY 7D96IR0PPM ONCASPAR (PEGASPARGASE) INJECTION, SOLUTION FOR INTRAMUSCULAR AND INTRAVENOUS USE [ENZON PHARMACEUTICALS, INC.] 1 sodium chloride INACTIVE INGREDIENT 451W47IQ8X ONCASPAR (PEGASPARGASE) INJECTION, SOLUTION FOR INTRAMUSCULAR AND INTRAVENOUS USE [ENZON PHARMACEUTICALS, INC.] 1 sodium phosphate, dibasic INACTIVE INGREDIENT GR686LBA74 ONCASPAR (PEGASPARGASE) INJECTION, SOLUTION FOR INTRAMUSCULAR AND INTRAVENOUS USE [ENZON PHARMACEUTICALS, INC.] 1 sodium phosphate, monobasic INACTIVE INGREDIENT 3980JIH2SW ONCASPAR (PEGASPARGASE) INJECTION, SOLUTION FOR INTRAMUSCULAR AND INTRAVENOUS USE [ENZON PHARMACEUTICALS, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R ONCASPAR (PEGASPARGASE) INJECTION, SOLUTION FOR INTRAMUSCULAR AND INTRAVENOUS USE [ENZON PHARMACEUTICALS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57665-002 ONCASPAR (PEGASPARGASE) INJECTION, SOLUTION FOR INTRAMUSCULAR AND INTRAVENOUS USE [ENZON PHARMACEUTICALS, INC.] 1 Legacy NDC, 2 package rows 20080808_D046EC54-9AC8-4C9F-87A7-69E9900D8016.zip
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 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Revcovi ELAPEGADEMASE-LVLR Chiesi USA, Inc. 8c073f84-cdd0-40e4-b3a9-172687267f28 2026-05-31 Warnings, Adverse reactions Exact identifier application number: BLA761092
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761092 Revcovi elapegademase-lvlr 351(a) Rx 2026-08-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57665-002-01 57665000201 1 VIAL in 1 CARTON (57665-002-01) > 1.5 mL in 1 VIAL 1 vial 2018-10-05 2022-08-31 No No Current 57665-002-02 57665000202 1 in 1 CARTON Historical