Acetaminophen And Codeine Phosphate
NDC Package 0121-0504-40

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

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

Acetaminophen And Codeine Phosphate is 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 toleratedHave not provided adequate analgesia, or are not expected to provide adequate analgesia. Marketed by Pai Holdings, Llc Dba Pai Pharma, this product is identified by NDC 0121-0504 and is authorized under FDA application ANDA087508.

Identification & Billing

NDC Package Code
0121-0504-40
Package Description
40 TRAY in 1 CASE / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0504-05)
Product Code
0121-0504
11-Digit Billing Format
00121050440
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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

Clinical Specifications

Proprietary Name
Acetaminophen And Codeine Phosphate
Dosage Form
-
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 toleratedHave not provided adequate analgesia, or are not expected to provide adequate analgesia

Regulatory & Marketing

Labeler Name
Pai Holdings, Llc Dba Pai Pharma
FDA Application #
ANDA087508
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-21-1981
End Marketing Date
04-30-2025
Listing Expiration
04-30-2025
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0121-0504). Click a package code to view its specific billing and regulatory data.

0121-0504-04
118 mL in 1 BOTTLE
0121-0504-05
5 mL in 1 CUP, UNIT-DOSE
0121-0504-16
473 mL in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0121-0504-40 identifies a specific commercial package of 40 tray in 1 case / 10 cup, unit-dose in 1 tray / 5 ml in 1 cup, unit-dose (0121-0504-05) of Acetaminophen And Codeine Phosphate, labeled by Pai Holdings, Llc Dba Pai Pharma. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Pai Holdings, Llc Dba Pai Pharma on August 21, 1981. The current certification is valid through April 30, 2025.

How is this Pai Holdings, Llc Dba Pai Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121050440. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0121-0504-40
11-Digit CMS (5-4-2)
00121-0504-40

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.