NDC Package 0121-0928-16 Promethazine With Codeine

View Billable Units, 11-Digit Format, RxNorm

Package Information
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

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

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

Labeler Name:

Pai Holdings, Llc Dba Pai Pharma

Sample Package:

FDA Application Number:

ANDA040650

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

09-18-2020

End Marketing Date:

09-30-2024

Listing Expiration Date:

09-30-2024

Exclude Flag:

Code Structure:

0121 - Pai Holdings, Llc Dba Pai Pharma
- 0121-0928 - Promethazine With Codeine
  - 0121-0928-16 - 473 mL in 1 BOTTLE

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, labeled by Pai Holdings, Llc Dba Pai Pharma. The product's dosage form is and is administered via form.

Is NDC 0121-0928 included in the NDC Directory?

No, Promethazine With Codeine with product code 0121-0928 is excluded from the NDC Directory because it was discontinued by the manufacturer. The product was first marketed by Pai Holdings, Llc Dba Pai Pharma on September 18, 2020 and its listing in the NDC Directory is set to expire on September 30, 2024 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
4-4-2	0121-0928-16	5-4-2	00121-0928-16

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