Humulin Injection, Solution
NDC Package 0002-8501-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Humulin (insulin human) injection is concentrated insulin regular is used with a proper diet and exercise program to control high blood sugar in people with diabetes who require large doses of insulin (more than 200 units per day). This formulation utilizes a injection, solution delivery system. Marketed by Eli Lilly And Company, this product is identified by NDC 0002-8501 and is authorized under FDA application BLA018780.

Identification & Billing

NDC Package Code
0002-8501-01
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 20 mL in 1 VIAL, MULTI-DOSE
Product Code
0002-8501
11-Digit Billing Format
00002850101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1731315 - regular insulin, human (concentrated) 500 UNT/ML in 3 ML Pen Injector
  • RxCUI: 1731315 - 3 ML insulin, regular, human 500 UNT/ML Pen Injector
  • RxCUI: 1731317 - HumuLIN R (concentrated) 500 UNT/ML in 3 ML Pen Injector
  • RxCUI: 1731317 - 3 ML insulin, regular, human 500 UNT/ML Pen Injector [Humulin R]
  • RxCUI: 1731317 - 3 ML Humulin R 500 UNT/ML Pen Injector

Clinical Specifications

Proprietary Name
Humulin R U-500
Non-Proprietary Name
Insulin Human
Substance Name
Insulin Human
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
INSULIN HUMAN 500 [iU]/mL
Pharmacologic Class
Usage Information
Concentrated insulin regular is used with a proper diet and exercise program to control high blood sugar in people with diabetes who require large doses of insulin (more than 200 units per day). Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. This man-made insulin product is the same as human insulin. It replaces the insulin that your body would normally make. It works right away like regular insulin but its effects last longer. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. This medication may be used alone or with other oral diabetes drugs (such as metformin).

Regulatory & Marketing

Labeler Name
Eli Lilly And Company
Product Type
Human Prescription Drug
FDA Application #
BLA018780
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-31-1994
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J1817
Source: PDAC
INSULIN FOR ADMINISTRATION THROUGH DME (I.E., INSULIN PUMP) PER 50 UNITS
HCPCS Dosage 50 U
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0002-8501-01 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 20 ml in 1 vial, multi-dose of Humulin R U-500, a human prescription drug labeled by Eli Lilly And Company. This injection, solution is formulated for subcutaneous use and contains insulin human as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Eli Lilly And Company on March 31, 1994. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Concentrated insulin regular is used with a proper diet and exercise program to control high blood sugar in people with diabetes who require large doses of insulin (more than 200 units per day). Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. This man-made insulin product is the same as human insulin. It replaces the insulin that your body would normally make. It works right away like regular insulin but its effects last longer. It works by helping blood sugar (glucose) get into cells so your body can use it for energy. This medication may be used alone or with other oral diabetes drugs (such as metformin).

How is this Eli Lilly And Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00002850101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0002-8501-01
11-Digit CMS (5-4-2)
00002-8501-01

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.