NDC codes

FDA NDC Directory
Product NDC (as listed)0169-1833Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00169-1833Add 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 NDC11-digit (billing)PackageCopy
0169-1833-02001691833021 VIAL in 1 CARTON (0169-1833-02) / 10 mL in 1 VIALMarketed from Jun 25, 1991
0169-1833-11001691833111 VIAL in 1 CARTON (0169-1833-11) / 10 mL in 1 VIALMarketed from Jun 25, 1991

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
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 0169-1833_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.

How CPT relates to drug billing

NDC on a medical claim

N400169183302 followed by a unit qualifier and the quantity

Package 00169-1833-02. 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under BLA 019938

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

FDA NDC Directory listings under BLA 019938
ProductStrengthForm · routeLabelerProduct NDC
Novolin Rhuman insulinInsulin human 100 [iU]/mLInjection, SolutionSubcutaneousNovo Nordisk0169-3003

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