NDC Package 50383-079-16 Acetaminophen And Codeine Phosphate

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 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:

50383-079-16

Package Description:

473 mL in 1 BOTTLE

Product Code:

50383-079

Proprietary Name:

Acetaminophen And Codeine Phosphate

Usage Information:

Acetaminophen and codeine phosphate oral solution is indicated for the management of mild to moderate pain where treatment with an opioid is appropriate and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see WARNINGS], reserve acetaminophen and codeine phosphate oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:•Have not been tolerated, or are not expected to be tolerated,•Have not provided adequate analgesia, or are not expected to provide adequate analgesia

11-Digit NDC Billing Format:

50383007916

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: 993755 - codeine phosphate 12 MG / acetaminophen 120 MG in 5 mL Oral Solution

RxCUI: 993755 - acetaminophen 24 MG/ML / codeine phosphate 2.4 MG/ML Oral Solution

RxCUI: 993755 - acetaminophen 120 MG / codeine phosphate 12 MG per 5 ML Oral Solution

RxCUI: 993755 - acetaminophen 300 MG / codeine phosphate 30 MG per 12.5 ML Oral Solution

RxCUI: 993755 - APAP 24 MG/ML / Codeine Phosphate 2.4 MG/ML Oral Solution

Labeler Name:

Akorn

Sample Package:

Start Marketing Date:

04-26-1996

Listing Expiration Date:

12-31-2023

Exclude Flag:

Code Structure:

50383 - Akorn
- 50383-079 - Acetaminophen And Codeine Phosphate
  - 50383-079-16 - 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 50383-079-16?

The NDC Packaged Code 50383-079-16 is assigned to a package of 473 ml in 1 bottle of Acetaminophen And Codeine Phosphate, labeled by Akorn. The product's dosage form is and is administered via form.

Is NDC 50383-079 included in the NDC Directory?

No, Acetaminophen And Codeine Phosphate with product code 50383-079 is excluded from the NDC Directory because it's listing has been INACTIVATED by FDA. The product was first marketed by Akorn on April 26, 1996 and its listing in the NDC Directory is set to expire on December 31, 2023 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 50383-079-16?

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 50383-079-16?

The 11-digit format is 50383007916. 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 Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	50383-079-16	5-4-2	50383-0079-16

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