NDC codes

FDA NDC Directory
Product NDC (as listed)0002-8797Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00002-8797Add 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
0002-8797-5900002879759000028797595 SYRINGE in 1 CARTON (0002-8797-59) / 3 mL in 1 SYRINGE (0002-8797-01)Marketed from Jan 16, 2008

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)
Humalog Mix75/25 KwikPenSuffix: Mix75/25 KwikPen
Generic name (nonproprietary)
insulin lispro
Active ingredients
Insulin lispro — 100 [iU]/mL
Dosage form
Injection, Suspension
Route
Subcutaneous
Labeler
Eli Lilly and CompanyNDC labeler code 0002
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 021017
Marketing start
Listing expires
Other FDA classes
Insulin (Chemical/Ingredient)
Identifiers
Product ID 0002-8797_272b1d09-c7ee-4ee3-abe1-ad200cb61df8SPL ID 272b1d09-c7ee-4ee3-abe1-ad200cb61df8SPL set ID c73da51a-1899-45ad-b6cf-9c52c36a25ddRxCUI 259111, 752388, 847252, 847254UNII GFX7QIS1IIUPC 0300027511016
Pharmacologic class
Insulin Analog

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

N400002879759 followed by a unit qualifier and the quantity

Package 00002-8797-59. 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)

HUMALOG Mix75/25 is indicated to improve glycemic control in adults with diabetes mellitus. HUMALOG ® Mix75/25™ is a mixture of insulin lispro protamine, an intermediate-acting human insulin analog, and insulin lispro, a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. ( 1 ) Limitations of Use: The proportions of rapid-acting and intermediate-acting insulins are fixed and do not allow for basal versus prandial dose adjustments. ( 1 ) Limitations of Use : The proportions of rapid-acting and intermediate-acting insulins in HUMALOG Mix75/25 are fixed and do not allow for basal versus prandial dose adjustments.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0002-8797

What is NDC 0002-8797?
0002-8797 is the product NDC for Humalog Mix75/25 KwikPen (insulin lispro), Insulin lispro 100 [iU]/mL injection, suspension, listed with the FDA by Eli Lilly and Company. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Humalog Mix75/25 KwikPen (Insulin lispro).
What is the active ingredient?
Insulin lispro.
Who is the labeler?
Eli Lilly and Company, NDC labeler code 0002. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Humalog Mix75/25 KwikPen?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under BLA 021017

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

FDA NDC Directory listings under BLA 021017
ProductStrengthForm · routeLabelerProduct NDC
Humalog Mix75/25insulin lisproInsulin lispro 100 [iU]/mLInjection, SuspensionSubcutaneousEli Lilly and Company0002-7511
Insulin Lispro Protamine and Insulin Lispro Injectable Suspension Mix75/25 KwikPeninsulin lisproInsulin lispro 100 [iU]/mLInjection, SuspensionSubcutaneousEli Lilly and Company0002-8233

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