Home NDC 0024-5844-05 Leukine
Product NDC 0024-5844
Requested package NDC 0024-5844-05
11-digit product format 000245844
Labeler code 0024
Product ID 0024-5844_ac281296-b49b-4f33-a16c-a83e60964713
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SARGRAMOSTIM
Dosage form LIQUID
Route INTRAVENOUS; SUBCUTANEOUS
Labeler sanofi-aventis U.S. LLC
Application BLA103362
Marketing category BLA
Marketing start 1996-12-01
Marketing end 2021-12-30
Substance SARGRAMOSTIM
Active strength 500 ug/mL
Pharmacologic classes Granulocyte Colony-Stimulating Factor [CS],Granulocyte-Macrophage Colony-Stimulating Factor [CS],Increased Myeloid Cell Production [PE],Leukocyte Growth Factor [EPC]
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 · 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…
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 SARGRAMOSTIM ACTIVE INGREDIENT 5TAA004E22 LEUKINE (SARGRAMOSTIM) LIQUID LEUKINE (SARGRAMOSTIM) INJECTION, POWDER, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 4 sargramostim ACTIVE MOIETY 5TAA004E22 LEUKINE (SARGRAMOSTIM) LIQUID LEUKINE (SARGRAMOSTIM) INJECTION, POWDER, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 4 BENZYL ALCOHOL INACTIVE INGREDIENT LKG8494WBH LEUKINE (SARGRAMOSTIM) LIQUID LEUKINE (SARGRAMOSTIM) INJECTION, POWDER, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 4 MANNITOL INACTIVE INGREDIENT 3OWL53L36A LEUKINE (SARGRAMOSTIM) LIQUID LEUKINE (SARGRAMOSTIM) INJECTION, POWDER, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 4 SUCROSE INACTIVE INGREDIENT C151H8M554 LEUKINE (SARGRAMOSTIM) LIQUID LEUKINE (SARGRAMOSTIM) INJECTION, POWDER, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 4 TROMETHAMINE INACTIVE INGREDIENT 023C2WHX2V LEUKINE (SARGRAMOSTIM) LIQUID LEUKINE (SARGRAMOSTIM) INJECTION, POWDER, FOR SOLUTION [SANOFI-AVENTIS U.S. LLC] 4
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 Leukine SARGRAMOSTIM Partner Therapeutics, Inc. bb9a3820-f31a-4dd9-bef4-97094c01a398 2024-12-06 Warnings, Adverse reactions Exact identifier application number: BLA103362
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 103362 Leukine sargramostim 351(a) Rx 2026-09-01
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0024-5844-05 00024584405 5 VIAL in 1 CARTON (0024-5844-05) > 1 mL in 1 VIAL 5 vial 1996-12-01 2021-12-30 No No Current