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  5. NDC Package Code: 62559-758-04 Promethazine Hydrochloride And Dextromethorphan Hydrobromide

NDC Package 62559-758-04 Promethazine Hydrochloride And Dextromethorphan Hydrobromide

Solution Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
62559-758-04
Package Description:
118 mL in 1 BOTTLE
Product Code:
62559-758
Proprietary Name:
Promethazine Hydrochloride And Dextromethorphan Hydrobromide
Non-Proprietary Name:
Promethazine Hydrochloride And Dextromethorphan Hydrobromide
Substance Name:
Dextromethorphan Hydrobromide; Promethazine Hydrochloride
Usage Information:
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
11-Digit NDC Billing Format:
62559075804
NDC to RxNorm Crosswalk:
  • RxCUI: 991528 - promethazine HCl 6.25 MG / dextromethorphan HBr 15 MG in 5 mL Oral Solution
  • RxCUI: 991528 - dextromethorphan hydrobromide 3 MG/ML / promethazine hydrochloride 1.25 MG/ML Oral Solution
  • RxCUI: 991528 - dextromethorphan HBr 15 MG / promethazine HCl 6.25 MG per 5 ML Oral Solution
Product Type:
Human Prescription Drug
Labeler Name:
Ani Pharmaceuticals, Inc.
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):
Sample Package:
No
FDA Application Number:
NDA011265
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:
09-05-2024
Listing Expiration Date:
12-31-2026
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.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
62559-758-16473 mL in 1 BOTTLE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 62559-758-04?

The NDC Packaged Code 62559-758-04 is assigned to a package of 118 ml in 1 bottle of Promethazine Hydrochloride And Dextromethorphan Hydrobromide, a human prescription drug labeled by Ani Pharmaceuticals, Inc.. The product's dosage form is solution and is administered via oral form.

Is NDC 62559-758 included in the NDC Directory?

Yes, Promethazine Hydrochloride And Dextromethorphan Hydrobromide with product code 62559-758 is active and included in the NDC Directory. The product was first marketed by Ani Pharmaceuticals, Inc. on September 05, 2024 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 62559-758-04?

The 11-digit format is 62559075804. 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 5-3-2 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
5-3-262559-758-045-4-262559-0758-04