Prescription drug · BLA
Humalog Mix75/25 KwikPen (insulin lispro) NDC 0002-8797
Insulin lispro 100 [iU]/mL · Injection, Suspension · Subcutaneous · Eli Lilly and Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0002-8797-59 | 00002879759 | 5 SYRINGE in 1 CARTON (0002-8797-59) / 3 mL in 1 SYRINGE (0002-8797-01)Marketed from Jan 16, 2008 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Humalog Mix75/25 KwikPenSuffix: Mix75/25 KwikPen
- Generic name (nonproprietary)
- insulin lispro
- Active ingredients
- Insulin lispro — 100 [iU]/mL
- Dosage form
- Injection, Suspension
- Route
- Subcutaneous
- Labeler
- Eli Lilly and Company
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 021017
- Marketing start
- Listing expires
- Other FDA classes
- Insulin (Chemical/Ingredient)
- Identifiers
- Product ID 0002-8797_272b1d09-c7ee-4ee3-abe1-ad200cb61df8SPL ID 272b1d09-c7ee-4ee3-abe1-ad200cb61df8SPL set ID c73da51a-1899-45ad-b6cf-9c52c36a25ddRxCUI 259111, 752388, 847252, 847254UNII GFX7QIS1IIUPC 0300027511016
- Pharmacologic class
- Insulin Analog
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
N400002879759followed by a unit qualifier and the quantityPackage 00002-8797-59. 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)
HUMALOG Mix75/25 is indicated to improve glycemic control in adults with diabetes mellitus. HUMALOG ® Mix75/25™ is a mixture of insulin lispro protamine, an intermediate-acting human insulin analog, and insulin lispro, a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. ( 1 ) Limitations of Use: The proportions of rapid-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments. ( 1 ) Limitations of Use : The proportions of rapid-acting and intermediate-acting insulins in HUMALOG Mix75/25 are fixed and do not allow for basal versus prandial dose adjustments.
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 021017
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPeninsulin lispro | Insulin lispro 100 [iU]/mL | Injection, SuspensionSubcutaneous | Eli Lilly and Company | 0002-8233 |
| Humalog Mix75/25insulin lispro | Insulin lispro 100 [iU]/mL | Injection, SuspensionSubcutaneous | Eli Lilly and Company | 0002-7511 |