Insulin Recombinant Human Crystal
NDC Package 0420-9004-01

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Insulin Recombinant Human crystals is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a crystal delivery system. Marketed by Novo Nordisk A/s, this product is identified by NDC 0420-9004.

Identification & Billing

NDC Package Code
0420-9004-01
Package Description
1000 g in 1 CONTAINER
Product Code
0420-9004
11-Digit Billing Format
00420900401

Clinical Specifications

Proprietary Name
Insulin Recombinant Human
Non-Proprietary Name
Insulin Recombinant Human
Substance Name
Insulin Human
Dosage Form
Crystal - A naturally produced angular solid of definite form in which the ultimate units from which it is built up are systematically arranged; they are usually evenly spaced on a regular space lattice.
Active Ingredient(s)
INSULIN HUMAN 1 g/g

Regulatory & Marketing

Labeler Name
Novo Nordisk A/s
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
03-24-2010
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0420-9004-01 identifies a specific commercial package of 1000 g in 1 container of Insulin Recombinant Human (UNFINISHED drug), a bulk ingredient labeled by Novo Nordisk A/s. This crystal is formulated for 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 Novo Nordisk A/s on March 24, 2010. The current certification is valid through December 31, 2026.

How is this Novo Nordisk A/s product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00420900401. 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)
0420-9004-01
11-Digit CMS (5-4-2)
00420-9004-01

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