1. Home
  2. Labeler Index
  3. Nucare Pharmaceuticals,inc.
  4. 68071-3551
  5. NDC Package Code: 68071-3551-4 Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution

NDC Package 68071-3551-4 Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution

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:
68071-3551-4
Package Description:
118 mL in 1 BOTTLE
Product Code:
68071-3551
Proprietary Name:
Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution
Non-Proprietary Name:
Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution
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:
68071355104
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:
Nucare 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:
ANDA040649
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
10-05-2020
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.

Frequently Asked Questions

What is NDC 68071-3551-4?

The NDC Packaged Code 68071-3551-4 is assigned to a package of 118 ml in 1 bottle of Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution, a human prescription drug labeled by Nucare Pharmaceuticals,inc.. The product's dosage form is solution and is administered via oral form.

Is NDC 68071-3551 included in the NDC Directory?

Yes, Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution with product code 68071-3551 is active and included in the NDC Directory. The product was first marketed by Nucare Pharmaceuticals,inc. on October 05, 2020 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 68071-3551-4?

The 11-digit format is 68071355104. 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
5-4-168071-3551-45-4-268071-3551-04