Novolin N (human insulin) NDC 0169-3004

NDC codes

FDA NDC Directory

Product NDC (as listed)0169-3004Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00169-3004Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0169-3004-15	00169300415	5 SYRINGE, PLASTIC in 1 CARTON (0169-3004-15) / 3 mL in 1 SYRINGE, PLASTIC (0169-3004-01)Marketed from Sep 6, 2019
0169-3004-25	00169300425	5 SYRINGE, PLASTIC in 1 CARTON (0169-3004-25) / 3 mL in 1 SYRINGE, PLASTIC (0169-3004-12)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 NSuffix: N
Generic name (nonproprietary): human insulin
Active ingredients: Insulin human — 100 [iU]/mL
Dosage form: Injection, Suspension
Route: Subcutaneous
Labeler: Novo Nordisk
Product type: Over-the-counter drug
Marketing category: BLA — Biologics License ApplicationApplication BLA 019959
Marketing start: Sep 6, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Insulin (Chemical structure)
Identifiers: Product ID 0169-3004_652d3fd6-809f-476e-9159-a1beffb9ea01SPL ID 652d3fd6-809f-476e-9159-a1beffb9ea01SPL set ID 82f1445c-b2c6-445a-82cf-ba8825fac776RxCUI 311027, 311028, 1654862, 2206099UNII 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.

How CPT relates to drug billing

NDC on a medical claim

N400169300415 followed by a unit qualifier and the quantity

Package 00169-3004-15. 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 Nov 23, 2022.

Indications (excerpt from the label)

NOVOLIN N is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. NOVOLIN N is an intermediate-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.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 019959

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under BLA 019959
Product	Strength	Form · route	Labeler	Product NDC
Novolin Nhuman insulin	Insulin human 100 [iU]/mL	Injection, SuspensionSubcutaneous	Novo Nordisk	0169-1834