Zepbound Injection, Solution
NDC Package 0002-2002-01

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

Package Information

Zepbound (tirzepatide) injection is zEPBOUND™ is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease). This formulation utilizes a injection, solution delivery system. Marketed by Eli Lilly And Company, this product is identified by NDC 0002-2002 and is authorized under FDA application NDA217806.

Identification & Billing

NDC Package Code
0002-2002-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE
Product Code
0002-2002
11-Digit Billing Format
00002200201
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zepbound
Non-Proprietary Name
Tirzepatide
Substance Name
Tirzepatide
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)
TIRZEPATIDE 15 mg/.5mL
Pharmacologic Class
Usage Information
ZEPBOUND™ is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of: 30 kg/m2 or greater (obesity) or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease). Limitations of UseZEPBOUND contains tirzepatide. Coadministration with other tirzepatide-containing products or with any glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended. The safety and efficacy of ZEPBOUND in combination with other products intended for weight management, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established. ZEPBOUND has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.5)].

Regulatory & Marketing

Labeler Name
Eli Lilly And Company
Product Type
Human Prescription Drug
FDA Application #
NDA217806
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
03-28-2024
Listing Expiration
12-31-2027
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0002-2002). Click a package code to view its specific billing and regulatory data.

0002-2002-04
4 VIAL, SINGLE-DOSE in 1 CARTON / .5 mL in 1 VIAL, SINGLE-DOSE

* 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 0002-2002-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / .5 ml in 1 vial, single-dose of Zepbound, a human prescription drug labeled by Eli Lilly And Company. This injection, solution is formulated for subcutaneous use and contains tirzepatide 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 28, 2024. The current certification is valid through December 31, 2027.

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: 00002200201. 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)
0002-2002-01
11-Digit CMS (5-4-2)
00002-2002-01

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