NDC Package 17856-0065-1 Promethazine Hydrochloride And Codeine Phosphate

View Billable Units, 11-Digit Format, RxNorm

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

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:
17856-0065-1
Package Description:
72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE / 5 mL in 1 CUP, UNIT-DOSE
Product Code:
Proprietary Name:
Promethazine Hydrochloride And Codeine Phosphate
Usage Information:
Promethazine HCl and Codeine Phosphate 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 UseNot 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), Use in Specific Populations (8.4)].Contraindicated in pediatric patients 12 to 18 years of age after tonsillectomy or adenoidectomy [see Contraindications (4), 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 HCl and Codeine Phosphate 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:
17856006501
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
  • Labeler Name:
    Atlantic Biologicals Corp.
    Sample Package:
    No
    Start Marketing Date:
    03-12-2018
    Listing Expiration Date:
    12-31-2021
    Exclude Flag:
    I
    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 17856-0065-1?

    The NDC Packaged Code 17856-0065-1 is assigned to a package of 72 cup, unit-dose in 1 box, unit-dose / 5 ml in 1 cup, unit-dose of Promethazine Hydrochloride And Codeine Phosphate, labeled by Atlantic Biologicals Corp.. The product's dosage form is and is administered via form.

    Is NDC 17856-0065 included in the NDC Directory?

    No, Promethazine Hydrochloride And Codeine Phosphate with product code 17856-0065 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Atlantic Biologicals Corp. on March 12, 2018 and its listing in the NDC Directory is set to expire on December 31, 2021 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 17856-0065-1?

    The 11-digit format is 17856006501. 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
    5-4-117856-0065-15-4-217856-0065-01