Over-the-counter drug · BLA
Humulin R (insulin human) NDC 0002-0213
Insulin human 100 [iU]/mL · Injection, Solution · Parenteral · Eli Lilly and Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0002-0213-01 | 00002021301 | 1 VIAL, MULTI-DOSE in 1 CARTON (0002-0213-01) / 3 mL in 1 VIAL, MULTI-DOSEMarketed from Jun 20, 2023 |
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 RSuffix: R
- Generic name (nonproprietary)
- insulin human
- Active ingredients
- Insulin human — 100 [iU]/mL
- Dosage form
- Injection, Solution
- Route
- Parenteral
- Labeler
- Eli Lilly and Company
- Product type
- Over-the-counter drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 018780
- Marketing start
- Marketing end
- Other FDA classes
- Insulin (Chemical structure)
- Identifiers
- Product ID 0002-0213_0225b9f7-8112-4b71-b513-c302c8b374b0SPL ID 0225b9f7-8112-4b71-b513-c302c8b374b0SPL set ID b519bd83-038c-4ec5-a231-a51ec5cc291fRxCUI 311034, 311036UNII 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.
- NDC on a medical claim
N400002021301followed by a unit qualifier and the quantityPackage 00002-0213-01. 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 is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. HUMULIN ® R is a short-acting human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. ( 1 )
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 R U-500 KwikPeninsulin human | Insulin human 500 [iU]/mL | Injection, SolutionSubcutaneous | Eli Lilly and Company | 0002-8824 |
| 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 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.