Acetaminophen And Codeine Phosphate Solution
NDC Package 64950-374-16

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

Acetaminophen And Codeine Phosphate solution is 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. This formulation utilizes a solution delivery system. Marketed by Genus Lifesciences Inc., this product is identified by NDC 64950-374 and is authorized under FDA application ANDA087508.

Identification & Billing

NDC Package Code
64950-374-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
64950-374
11-Digit Billing Format
64950037416
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
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
Non-Proprietary Name
Acetaminophen And Codeine Phosphate
Substance Name
Acetaminophen; Codeine Phosphate
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
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.
DEA Schedule
Schedule V (CV) Substances

Regulatory & Marketing

Labeler Name
Genus Lifesciences Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA087508
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-10-2023
Listing Expiration
12-31-2027
Exclude Flag
N
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 (64950-374). Click a package code to view its specific billing and regulatory data.

64950-374-04
118 mL in 1 BOTTLE, PLASTIC

* 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 64950-374-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Acetaminophen And Codeine Phosphate, a human prescription drug labeled by Genus Lifesciences Inc.. This solution is formulated for oral use and contains acetaminophen; codeine phosphate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Genus Lifesciences Inc. on August 10, 2023. The current certification is valid through December 31, 2027.

How is this Genus Lifesciences Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64950037416. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 total billable units per package. 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 (5-3-2)
64950-374-16
11-Digit CMS (5-4-2)
64950-0374-16

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