Indocin Suppository
NDC Package 69344-102-33

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

Package Information

Indocin (indomethacin) suppositories is indomethacin is used to relieve pain, swelling, and joint stiffness caused by arthritis, gout, bursitis, and tendonitis. This formulation utilizes a suppository delivery system. Marketed by Zyla Life Sciences Us Inc., this product is identified by NDC 69344-102 and is authorized under FDA application ANDA073314.

Identification & Billing

NDC Package Code
69344-102-33
Package Description
30 SUPPOSITORY in 1 BOX
Product Code
69344-102
11-Digit Billing Format
69344010233
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Indocin
Non-Proprietary Name
Indomethacin
Substance Name
Indomethacin
Dosage Form
Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
INDOMETHACIN 50 mg/1
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 Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA073314
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-31-1992
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 69344-102-33 identifies a specific commercial package of 30 suppository in 1 box of Indocin, a human prescription drug labeled by Zyla Life Sciences Us Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This suppository is formulated for rectal 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 Inc. on August 31, 1992. 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 Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69344010233. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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)
69344-102-33
11-Digit CMS (5-4-2)
69344-0102-33

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