Indocin Suspension
NDC Package 69344-101-01

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

Package Information

Indocin (indomethacin) suspension is indomethacin is used to relieve pain, swelling, and joint stiffness caused by arthritis, gout, bursitis, and tendonitis. This formulation utilizes a suspension delivery system. Marketed by Zyla Life Sciences Us Llc, this product is identified by NDC 69344-101 and is authorized under FDA application NDA018332.

Identification & Billing

NDC Package Code
69344-101-01
Package Description
1 BOTTLE, GLASS in 1 CARTON / 237 mL in 1 BOTTLE, GLASS
Product Code
69344-101
11-Digit Billing Format
69344010101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Indocin
Non-Proprietary Name
Indomethacin
Substance Name
Indomethacin
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
INDOMETHACIN 25 mg/5mL
Pharmacologic Class
Usage Information
Indomethacin is used to relieve pain, swelling, and joint stiffness caused by arthritis, gout, bursitis, and tendonitis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

Regulatory & Marketing

Labeler Name
Zyla Life Sciences Us Llc
Product Type
Human Prescription Drug
FDA Application #
NDA018332
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-04-2019
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69344-101-01 identifies a specific commercial package of 1 bottle, glass in 1 carton / 237 ml in 1 bottle, glass of Indocin, a human prescription drug labeled by Zyla Life Sciences Us Llc. This suspension is formulated for oral use and contains indomethacin 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 Zyla Life Sciences Us Llc on February 04, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Indomethacin is used to relieve pain, swelling, and joint stiffness caused by arthritis, gout, bursitis, and tendonitis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain. See also Warning section.

How is this Zyla Life Sciences Us Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69344010101. 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 (5-3-2)
69344-101-01
11-Digit CMS (5-4-2)
69344-0101-01

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