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  5. NDC Package Code: 0121-0928-16 Promethazine With Codeine

NDC Package 0121-0928-16 Promethazine With Codeine

Promethazine Hydrochloride And Codeine Phosphate 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:
0121-0928-16
Package Description:
473 mL in 1 BOTTLE
Product Code:
0121-0928
Proprietary Name:
Promethazine With Codeine
Non-Proprietary Name:
Promethazine Hydrochloride And Codeine Phosphate
Substance Name:
Codeine Phosphate; Promethazine Hydrochloride
Usage Information:
Promethazine with Codeine Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold in patients 18 years of age and older.Important Limitations of Use• Not indicated for pediatric patients under 18 years of age [see Use in Specific Populations ( 8.4)]. • Contraindicated in pediatric patients under 12 years of age [see Contraindications ( 4) and Use in Specific Populations ( 8.4)]. • Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy and/or adenoidectomy [see Contraindications ( 4) and Use in    Specific Populations ( 8.4)]. • Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.1)], reserve    Promethazine with Codeine Oral Solution 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:
00121092816
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
473 ML
NDC to RxNorm Crosswalk:
  • RxCUI: 991486 - codeine phosphate 10 MG / promethazine HCl 6.25 MG in 5 mL Oral Solution
  • RxCUI: 991486 - codeine phosphate 2 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution
  • RxCUI: 991486 - codeine phosphate 10 MG / promethazine HCl 6.25 MG per 5 ML Oral Syrup
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Pai Holdings, Llc
    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):
  • CODEINE PHOSPHATE 10 mg/5mL
  • PROMETHAZINE HYDROCHLORIDE 6.25 mg/5mL
    • Pharmacologic Class(es):
  • Full Opioid Agonists - [MoA] (Mechanism of Action)
  • Opioid Agonist - [EPC] (Established Pharmacologic Class)
  • Phenothiazine - [EPC] (Established Pharmacologic Class)
  • Phenothiazines - [CS]
    • DEA Schedule:
    Schedule V (CV) Substances
    Sample Package:
    No
    FDA Application Number:
    ANDA040650
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    09-18-2020
    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 0121-0928-16?

    The NDC Packaged Code 0121-0928-16 is assigned to a package of 473 ml in 1 bottle of Promethazine With Codeine, a human prescription drug labeled by Pai Holdings, Llc. The product's dosage form is solution and is administered via oral form.

    Is NDC 0121-0928 included in the NDC Directory?

    Yes, Promethazine With Codeine with product code 0121-0928 is active and included in the NDC Directory. The product was first marketed by Pai Holdings, Llc on September 18, 2020 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 0121-0928-16?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 473.

    What is the 11-digit format for NDC 0121-0928-16?

    The 11-digit format is 00121092816. 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
    4-4-20121-0928-165-4-200121-0928-16