Over-the-counter drug · BLA
Novolin R (Human insulin) NDC 0169-3003
Insulin human 100 [iU]/mL · Injection, Solution · Subcutaneous · Novo Nordisk
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0169-3003-15 | 0016930031500169300315 | 5 SYRINGE, PLASTIC in 1 CARTON (0169-3003-15) / 3 mL in 1 SYRINGE, PLASTIC (0169-3003-01)Marketed from Sep 6, 2019 | |
| 0169-3003-25 | 0016930032500169300325 | 5 SYRINGE, PLASTIC in 1 CARTON (0169-3003-25) / 3 mL in 1 SYRINGE, PLASTIC (0169-3003-12)Marketed from Sep 6, 2019 |
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)
- Novolin RSuffix: R
- Generic name (nonproprietary)
- human insulin
- Active ingredients
- Insulin human — 100 [iU]/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Novo NordiskNDC labeler code 0169
- Product type
- Over-the-counter drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 019938
- Marketing start
- Listing expires
- Other FDA classes
- Insulin (Chemical structure)
- Identifiers
- Product ID 0169-3003_46700b71-3f26-4aaa-8eb7-6ceeeb515c79SPL ID 46700b71-3f26-4aaa-8eb7-6ceeeb515c79SPL set ID aee7f1f3-612c-4027-8ce9-4fd1f41eed71RxCUI 311033, 311034, 2206090, 2206092UNII 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
N400169300315followed by a unit qualifier and the quantityPackage 00169-3003-15. 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)
NOVOLIN R is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. NOVOLIN R is a short-acting human insulin indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 0169-3003
- What is NDC 0169-3003?
- 0169-3003 is the product NDC for Novolin R (human insulin), Insulin human 100 [iU]/mL injection, solution, listed with the FDA by Novo Nordisk. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Novolin R (Human Insulin).
- What is the active ingredient?
- Insulin human.
- Who is the labeler?
- Novo Nordisk, NDC labeler code 0169. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Novolin R?
- 1 other product NDC are listed under this name. See all Novolin R NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Novolin R products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Novolin Rhuman insulin | Insulin human 100 [iU]/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-1833 | 00169-1833-0200169-1833-11 |
Other NDCs under BLA 019938
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 |
|---|---|---|---|---|
| Novolin Rhuman insulin | Insulin human 100 [iU]/mL | Injection, SolutionSubcutaneous | Novo Nordisk | 0169-1833 |