Prescription drug · BLA
Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen (Insulin lispro) NDC 0002-8233
Insulin lispro 100 [iU]/mL · Injection, Suspension · Subcutaneous · Eli Lilly and Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0002-8233-05 | 0000282330500002823305 | 5 SYRINGE in 1 CARTON (0002-8233-05) / 3 mL in 1 SYRINGE (0002-8233-01)Marketed from Feb 12, 2020 |
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)
- Insulin Lispro Protamine and Insulin Lispro Injectable Suspension 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 CompanyNDC labeler code 0002
- 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 0002-8233_03dce3f6-da85-4635-9c62-478226005b60SPL ID 03dce3f6-da85-4635-9c62-478226005b60SPL set ID e49f701d-c19f-4cb2-b63f-01a917b33abcRxCUI 847252UNII GFX7QIS1II
- 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
N400002823305followed by a unit qualifier and the quantityPackage 00002-8233-05. 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)
Insulin Lispro Protamine and Insulin Lispro Mix75/25 is indicated to improve glycemic control in adults with diabetes mellitus. Insulin Lispro Protamine and Insulin Lispro 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 Insulin Lispro Protamine and Insulin Lispro Mix…
Excerpt only. Read the full label for complete information.
About NDC 0002-8233
- What is NDC 0002-8233?
- 0002-8233 is the product NDC for Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen, Insulin lispro 100 [iU]/mL injection, suspension, listed with the FDA by Eli Lilly and Company. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen (Insulin lispro).
- What is the active ingredient?
- Insulin lispro.
- Who is the labeler?
- Eli Lilly and Company, NDC labeler code 0002. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPen?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
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 |
|---|---|---|---|---|
| Humalog Mix75/25insulin lispro | Insulin lispro 100 [iU]/mL | Injection, SuspensionSubcutaneous | Eli Lilly and Company | 0002-7511 |
| Humalog Mix75/25 KwikPeninsulin lispro | Insulin lispro 100 [iU]/mL | Injection, SuspensionSubcutaneous | Eli Lilly and Company | 0002-8797 |