Prescription drug · BLA
Leukine (sargramostim) NDC 71837-5843
Sargramostim 250 ug/mL · Injection, Powder, Lyophilized, For solution · Intravenous, Subcutaneous · Partner Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71837-5843-5 | 71837584305 | 5 VIAL, SINGLE-DOSE in 1 CARTON (71837-5843-5) / 1 mL in 1 VIAL, SINGLE-DOSE (71837-5843-1)Marketed from Sep 1, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Leukine
- Generic name (nonproprietary)
- sargramostim
- Active ingredients
- Sargramostim — 250 ug/mL
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous, Subcutaneous
- Labeler
- Partner Therapeutics, Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 103362
- Marketing start
- Listing expires
- Other FDA classes
- Granulocyte Colony-Stimulating Factor (Chemical structure)Granulocyte-Macrophage Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
- Identifiers
- Product ID 71837-5843_4ad3993c-6c7f-4a33-8ead-a912636ff4a1SPL ID 4ad3993c-6c7f-4a33-8ead-a912636ff4a1SPL set ID bb9a3820-f31a-4dd9-bef4-97094c01a398RxCUI 208083, 315199UNII 5TAA004E22UPC 0371837584354
- Pharmacologic class
- Leukocyte Growth Factor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N471837584305followed by a unit qualifier and the quantityPackage 71837-5843-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
LEUKINE is a leukocyte growth factor indicated: To shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death following induction chemotherapy in adult patients 55 years and older with acute myeloid leukemia (AML). ( 1.1 ) For the mobilization of hematopoietic progenitor cells into peripheral blood for collection by leukapheresis and autologous transplantation in adult patients. ( 1.2 ) For the acceleration of myeloid reconstitution following autologous bone marrow or peripheral blood progenitor cell transplantation in adult and pediatric patients 2 years of age and older. ( 1.3 ) For the acceleration of myeloid…
Excerpt only. Read the full label for complete information.