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  5. NDC Package Code: 0121-1036-40 Hydrocodone Bitartrate And Homatropine Methylbromide

NDC Package 0121-1036-40 Hydrocodone Bitartrate And Homatropine Methylbromide

Solution 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:
0121-1036-40
Package Description:
4 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1036-05)
Product Code:
0121-1036
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 is indicated for the symptomatic relief of cough in adult patients 18 years of age and older. Limitations of Use:Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations (8.4)]. Contraindicated in pediatric patients less than 6 years of age [see Contraindications (4)].Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve hydrocodone bitartrate and homatropine methylbromide for use in adult patients for whom the benefits of cough suppression are expected to outweigh the risks, and in whom an adequate assessment of the etiology of the cough has been made.
11-Digit NDC Billing Format:
00121103640
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:
Pai Holdings, Llc Dba Pai Pharma
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Pharmacologic Class(es):
DEA Schedule:
Schedule II (CII) Substances
Sample Package:
No
FDA Application Number:
NDA005213
Marketing Category:
NDA AUTHORIZED GENERIC - A product marketed as a "generic" drug under an approved New Drug Application (NDA), rather than an Abbreviated New Drug Application (ANDA),.
Start Marketing Date:
08-05-2024
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 0121-1036-40?

The NDC Packaged Code 0121-1036-40 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 (0121-1036-05) of Hydrocodone Bitartrate And Homatropine Methylbromide, a human prescription drug labeled by Pai Holdings, Llc Dba Pai Pharma. The product's dosage form is solution and is administered via oral form.

Is NDC 0121-1036 included in the NDC Directory?

Yes, Hydrocodone Bitartrate And Homatropine Methylbromide with product code 0121-1036 is active and included in the NDC Directory. The product was first marketed by Pai Holdings, Llc Dba Pai Pharma on August 05, 2024 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 0121-1036-40?

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 0121-1036-40?

The 11-digit format is 00121103640. 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
4-4-20121-1036-405-4-200121-1036-40