NDC codes

FDA NDC Directory
Product NDC (as listed)0002-7516Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00002-7516Add 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
0002-7516-59000027516595 CARTRIDGE in 1 CARTON (0002-7516-59) / 3 mL in 1 CARTRIDGE (0002-7516-01)Marketed from Jul 26, 2000

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
Generic name (nonproprietary)
insulin lispro
Active ingredients
Insulin lispro100 [iU]/mL
Dosage form
Injection, Solution
Route
Intravenous, Subcutaneous
Product type
Prescription drug
Marketing category
BLA — Biologics License ApplicationApplication BLA 020563
Marketing start
Listing expires
Other FDA classes
Insulin (Chemical/Ingredient)
Identifiers
Product ID 0002-7516_03be5386-187a-420f-9021-55778a73eba0SPL ID 03be5386-187a-420f-9021-55778a73eba0SPL set ID c8ecbd7a-0e22-4fc7-a503-faa58c1b6f3fRxCUI 242120, 865098, 1652239, 1652242, 1652639, 1652640, 1652644, 1652646, 1926331, 1926332, 2621571, 2621572UNII GFX7QIS1II, 059QF0KO0R
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

N400002751659 followed by a unit qualifier and the quantity

Package 00002-7516-59. 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 is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. HUMALOG is a rapid acting human insulin analog indicated to improve glycemic control in adult 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 020563

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

FDA NDC Directory listings under BLA 020563
ProductStrengthForm · routeLabelerProduct NDC
Insulin LisproInsulin lispro 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousA-S Medication Solutions50090-5391
Humalog KwikPeninsulin lisproInsulin lispro 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousEli Lilly and Company0002-8799
Sterile DiluentdiluentWater 1 mL/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-0800
Humaloginsulin lisproInsulin lispro 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousA-S Medication Solutions50090-4488
Insulin Lispro Junior KwikPeninsulin lisproInsulin lispro 100 [iU]/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-7752
Humaloginsulin lisproInsulin lispro 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousEli Lilly and Company0002-7510
Humalog Junior KwikPeninsulin lisproInsulin lispro 100 [iU]/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-7714
Insulin Lispro KwikPeninsulin lisproInsulin lispro 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousEli Lilly and Company0002-8222
Humaloginsulin lisproInsulin lispro 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousA-S Medication Solutions50090-1375
Humalog KwikPeninsulin lisproInsulin lispro 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousA-S Medication Solutions50090-4073
Insulin LisproInsulin lispro 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousEli Lilly and Company0002-7737
Humalog KwikPeninsulin lisproInsulin lispro 100 [iU]/mLInjection, SolutionIntravenous, SubcutaneousA-S Medication Solutions50090-1663
Humalog Tempo Peninsulin lisproInsulin lispro 100 [iU]/mLInjection, SolutionSubcutaneousEli Lilly and Company0002-8213

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