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  5. NDC Package Code: 10191-1034-2 Codeinum

NDC Package 10191-1034-2 Codeinum

Codeine Pellet Sublingual - 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:
10191-1034-2
Package Description:
165 PELLET in 1 VIAL, GLASS
Product Code:
10191-1034
Proprietary Name:
Codeinum
Non-Proprietary Name:
Codeine
Substance Name:
Codeine Anhydrous
Usage Information:
Disolve 3 or 4 pellets in mouth or under tongue 3 times a day or as directed by a physician. Children 2 years and older take 1/2 adult dose.
11-Digit NDC Billing Format:
10191103402
Product Type:
Human Prescription Drug
Labeler Name:
Remedy Makers
Dosage Form:
Pellet - A small sterile solid mass consisting of a highly purified drug (with or without excipients) made by the formation of granules, or by compression and molding.
Administration Route(s):
  • Sublingual - Administration beneath the tongue.
    • Active Ingredient(s):
  • CODEINE ANHYDROUS 6 [hp_X]/1
    • Pharmacologic Class(es):
  • Full Opioid Agonists - [MoA] (Mechanism of Action)
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    Marketing Category:
    UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
    Start Marketing Date:
    07-10-2015
    Listing Expiration Date:
    12-31-2024
    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 10191-1034-2?

    The NDC Packaged Code 10191-1034-2 is assigned to a package of 165 pellet in 1 vial, glass of Codeinum, a human prescription drug labeled by Remedy Makers. The product's dosage form is pellet and is administered via sublingual form.

    Is NDC 10191-1034 included in the NDC Directory?

    Yes, Codeinum with product code 10191-1034 is active and included in the NDC Directory. The product was first marketed by Remedy Makers on July 10, 2015 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 10191-1034-2?

    The 11-digit format is 10191103402. 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
    5-4-110191-1034-25-4-210191-1034-02