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  5. NDC Package Code: 63629-8435-1 Belladonna And Opium

NDC Package 63629-8435-1 Belladonna And Opium

Atropa Belladonna And Opium Suppository Rectal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
63629-8435-1
Package Description:
12 PACKET in 1 BOX / 1 SUPPOSITORY in 1 PACKET
Product Code:
63629-8435
Proprietary Name:
Belladonna And Opium
Non-Proprietary Name:
Atropa Belladonna And Opium
Substance Name:
Atropa Belladonna; Opium
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
11-Digit NDC Billing Format:
63629843501
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
12 EA
NDC to 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
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Bryant Ranch Prepack
    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(s):
  • Rectal - Administration to the rectum.
    • Active Ingredient(s):
  • ATROPA BELLADONNA 16.2 mg/1
  • OPIUM 30 mg/1
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    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 Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 63629-8435-1?

    The NDC Packaged Code 63629-8435-1 is assigned to a package of 12 packet in 1 box / 1 suppository in 1 packet of Belladonna And Opium, a human prescription drug labeled by Bryant Ranch Prepack. The product's dosage form is suppository and is administered via rectal form.This product is billed for "EA" each discreet unit and contains an estimated amount of 12 billable units per package.

    Is NDC 63629-8435 included in the NDC Directory?

    Yes, Belladonna And Opium with product code 63629-8435 is active and included in the NDC Directory. The product was first marketed by Bryant Ranch Prepack on May 01, 1994 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 63629-8435-1?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 12.

    What is the 11-digit format for NDC 63629-8435-1?

    The 11-digit format is 63629843501. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-4-1 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-4-163629-8435-15-4-263629-8435-01