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  5. NDC Package Code: 0121-4811-40 Hydrocodone Bitartrate And Homatropine Methylbromide

NDC Package 0121-4811-40 Hydrocodone Bitartrate And Homatropine Methylbromide

Syrup Oral - 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:
0121-4811-40
Package Description:
4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4811-05)
Product Code:
0121-4811
Proprietary Name:
Hydrocodone Bitartrate And Homatropine Methylbromide
Non-Proprietary Name:
Hydrocodone Bitartrate And Homatropine Methylbromide
Substance Name:
Homatropine Methylbromide; Hydrocodone Bitartrate
Usage Information:
Hydrocodone bitartrate and homatropine methylbromide syrup is indicated for the symptomatic relief of cough in adults and children 6 years of age and older.
11-Digit NDC Billing Format:
00121481140
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 992668 - HYDROcodone bitartrate 5 MG / homatropine methylbromide 1.5 MG in 5 mL Oral Solution
  • RxCUI: 992668 - homatropine methylbromide 0.3 MG/ML / hydrocodone bitartrate 1 MG/ML Oral Solution
  • RxCUI: 992668 - homatropine methylbromide 1.5 MG / hydrocodone bitartrate 5 MG per 5 ML Syrup
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pharmaceutical Associates, Inc.
    Dosage Form:
    Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • HOMATROPINE METHYLBROMIDE 1.5 mg/5mL
  • HYDROCODONE BITARTRATE 5 mg/5mL
    • Pharmacologic Class(es):
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
  • Opioid Agonists - [MoA] (Mechanism of Action)
    • DEA Schedule:
    Schedule II (CII) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA088008
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    12-28-2009
    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 0121-4811-40?

    The NDC Packaged Code 0121-4811-40 is assigned to a package of 4 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose (0121-4811-05) of Hydrocodone Bitartrate And Homatropine Methylbromide, a human prescription drug labeled by Pharmaceutical Associates, Inc.. The product's dosage form is syrup and is administered via oral form.

    Is NDC 0121-4811 included in the NDC Directory?

    Yes, Hydrocodone Bitartrate And Homatropine Methylbromide with product code 0121-4811 is active and included in the NDC Directory. The product was first marketed by Pharmaceutical Associates, Inc. on December 28, 2009 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 NDC billing unit for package 0121-4811-40?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0121-4811-40?

    The 11-digit format is 00121481140. 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 4-4-2 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
    4-4-20121-4811-405-4-200121-4811-40