Belladonna And Opium Suppository
NDC Package 63629-8436-1

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

Package Information

Belladonna And Opium (atropa belladonna and opium) suppositories is belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:•Have not been tolerated, or are not expected to be tolerated,•Have not provided adequate analgesia, or are not expected to provide adequate analgesic. This formulation utilizes a suppository delivery system. Marketed by Bryant Ranch Prepack, this product is identified by NDC 63629-8436.

Identification & Billing

NDC Package Code
63629-8436-1
Package Description
4 PACKET in 1 BOX / 1 SUPPOSITORY in 1 PACKET
Product Code
63629-8436
11-Digit Billing Format
63629843601
RxNorm Crosswalk
  • RxCUI: 312104 - belladonna 16.2 MG / opium 30 MG Rectal Suppository
  • RxCUI: 312104 - belladonna alkaloids 16.2 MG / opium 30 MG Rectal Suppository

Clinical Specifications

Proprietary Name
Belladonna And Opium
Non-Proprietary Name
Atropa Belladonna And Opium
Substance Name
Atropa Belladonna; Opium
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)
Usage Information
Belladonna and opium suppositories are indicated for the management of ureteral spasm pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve belladonna and opium suppositories for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]:•Have not been tolerated, or are not expected to be tolerated,•Have not provided adequate analgesia, or are not expected to provide adequate analgesic
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Bryant Ranch Prepack
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
05-01-1994
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 63629-8436-1 identifies a specific commercial package of 4 packet in 1 box / 1 suppository in 1 packet of Belladonna And Opium, a human prescription drug labeled by Bryant Ranch Prepack. This suppository is formulated for rectal use and contains atropa belladonna; 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 Bryant Ranch Prepack on May 01, 1994. The current certification is valid through December 31, 2026.

How is this Bryant Ranch Prepack product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 63629843601. 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)
63629-8436-1
11-Digit CMS (5-4-2)
63629-8436-01

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