Home NDC 0024-5747-02 ADLYXIN
Product NDC 0024-5747
Requested package NDC 0024-5747-02
11-digit product format 000245747
Labeler code 0024
Product ID 0024-5747_7ea21219-5fcf-4575-acfd-7ff02629e07b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Lixisenatide
Dosage form INJECTION, SOLUTION
Route SUBCUTANEOUS
Labeler sanofi-aventis U.S. LLC
Application BLA208471
Marketing category BLA
Marketing start 2016-07-27
Marketing end 0000-00-00
Substance LIXISENATIDE
Active strength 100 ug/mL
Pharmacologic classes GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 208471 Adlyxin lixisenatide 351(a) Disc 2026-07-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0024-5747-02 00024574702 2 SYRINGE in 1 CARTON (0024-5747-02) > 3 mL in 1 SYRINGE 2 syringe 2016-07-27 0000-00-00 No No Current