Opium Tincture Liquid
NDC Package 59116-4580-9

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.

Opium Tincture liquids is a medication used to treat diarrhea. This formulation utilizes a liquid delivery system. Marketed by Cambrex Charles City, Inc, this product is identified by NDC 59116-4580.

Identification & Billing

NDC Package Code
59116-4580-9
Package Description
200 kg in 1 DRUM
Product Code
59116-4580
11-Digit Billing Format
59116458009

Clinical Specifications

Proprietary Name
Opium Tincture
Non-Proprietary Name
Opium Tincture
Substance Name
Opium
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
OPIUM 1 kg/kg
Usage Information
This medication is used to treat diarrhea. It helps to decrease how often you have bowel movements. It works by slowing the movement of the intestines. Opium belongs to a class of drugs known as opioid pain relievers, but this medication acts mainly to slow the gut.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Cambrex Charles City, Inc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
10-26-2012
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 59116-4580-9 identifies a specific commercial package of 200 kg in 1 drum of Opium Tincture (UNFINISHED drug), a bulk ingredient labeled by Cambrex Charles City, Inc. This liquid is formulated for use and contains opium 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 Cambrex Charles City, Inc on October 26, 2012. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat diarrhea. It helps to decrease how often you have bowel movements. It works by slowing the movement of the intestines. Opium belongs to a class of drugs known as opioid pain relievers, but this medication acts mainly to slow the gut.

How is this Cambrex Charles City, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59116458009. 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 (5-4-1)
59116-4580-9
11-Digit CMS (5-4-2)
59116-4580-09

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