Leukine
- Product NDC
- 0024-5844
- 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
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0024-5844 | D | Discontinued by firm | 2026-10-05 | ||
| excluded package | package | 0024-5844 | 0024-5844-01 | D | Discontinued by firm | 2026-10-05 | |
| excluded package | package | 0024-5844 | 0024-5844-05 | D | Discontinued by firm | 2026-10-05 |
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.
| 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 | 0024-5844-01 | d630ba8d3edf… | 732f749b63fb… |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 0024-5844-05 | 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 | 0024-5844-01 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 0024-5844-05 | 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 | 0024-5844-01 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 0024-5844-05 | 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 | 0024-5844-01 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 0024-5844-05 | 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 | 0024-5844-01 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 0024-5844-05 | 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 | 0024-5844-01 | cdf11ea48f46… | ba0047e9e063… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 0024-5844-05 | 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 | 0024-5844-01 | 302b2466d912… | e7b80fea0513… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 0024-5844-05 | 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 | 0024-5844-01 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 0024-5844-05 | 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 | 0024-5844-01 | 0efc9e666f02… | f202fb6c5f17… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 0024-5844-05 | 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 | 0024-5844-01 | ad56d346431e… | cc804d4bbf1e… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 0024-5844-05 | 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 | 0024-5844-01 | 367a005e9d99… | 383a685ebd0f… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0024-5844-05 | 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 | 0024-5844-01 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 0024-5844-05 | 557ba5c1ecfa… | 9c80585c8c6e… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients#
| 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.
| 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 | BLA103362 |
Purple Book Biologic Products#
| 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 | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0024-5844-01 | 00024584401 | 1 VIAL, MULTI-DOSE in 1 CARTON (0024-5844-01) > 1 mL in 1 VIAL, MULTI-DOSE | 1996-12-01 | 2021-12-30 | No | No | Current | |
| 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 |