Prescription drug · BLA
Humulin R U-500 KwikPen (insulin human) NDC 0002-8824
Insulin human 500 [iU]/mL · Injection, Solution · Subcutaneous · Eli Lilly and Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0002-8824-27 | 00002882427 | 2 SYRINGE in 1 CARTON (0002-8824-27) / 3 mL in 1 SYRINGEMarketed from Mar 25, 2016 |
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)
- Humulin R U-500 KwikPenSuffix: R U-500 KwikPen
- Generic name (nonproprietary)
- insulin human
- Active ingredients
- Insulin human — 500 [iU]/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Eli Lilly and Company
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 018780
- Marketing start
- Listing expires
- Other FDA classes
- Insulin (Chemical structure)
- Identifiers
- Product ID 0002-8824_6b516e71-16e8-4d6b-9a62-8f33e51daad4SPL ID 6b516e71-16e8-4d6b-9a62-8f33e51daad4SPL set ID b60e8dd0-1d48-4dc9-87fd-e14675255e8cRxCUI 249220, 351859, 1731315, 1731317UNII 1Y17CTI5SR
- Pharmacologic class
- Insulin
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
N400002882427followed by a unit qualifier and the quantityPackage 00002-8824-27. 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)
HUMULIN R U-500 is a concentrated human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day. HUMULIN ® R U-500 is a concentrated human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day. ( 1 ) Limitation of Use: The safety and efficacy of HUMULIN R U-500 used in combination with other insulins has not been determined. The safety and efficacy of HUMULIN R U-500 delivered by continuous subcutaneous infusion has not been determined. ( 1.1 ) 1.1 Limitation of Use The safety and efficacy of HUMULIN R U…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 018780
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 |
|---|---|---|---|---|
| Humulin Rinsulin human | Insulin human 100 [iU]/mL | Injection, SolutionParenteral | Eli Lilly and Company | 0002-0213 |
| Humulin Rinsulin human | Insulin human 100 [iU]/mL | Injection, SolutionParenteral | Eli Lilly and Company | 0002-8215 |
| Humulin Rinsulin human | Insulin human 100 [iU]/mL | Injection, SolutionParenteral | A-S Medication Solutions | 50090-0353 |