Acetaminophen And Codeine Phosphate Tablet
NDC Package 64850-643-01

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 tablets are 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 tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]Have not provided adequate analgesia, or are not expected to provide adequate analgesia,Have not been tolerated, or are not expected to be tolerated. This formulation utilizes a tablet delivery system. Marketed by Elite Laboratories, Inc., this product is identified by NDC 64850-643 and is authorized under FDA application ANDA212418.

Identification & Billing

NDC Package Code
64850-643-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
64850-643
11-Digit Billing Format
64850064301
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
  • RxCUI: 993770 - codeine phosphate 15 MG / acetaminophen 300 MG Oral Tablet
  • RxCUI: 993770 - acetaminophen 300 MG / codeine phosphate 15 MG Oral Tablet
  • RxCUI: 993770 - APAP 300 MG / codeine phosphate 15 MG Oral Tablet
  • RxCUI: 993781 - codeine phosphate 30 MG / acetaminophen 300 MG Oral Tablet
  • RxCUI: 993781 - acetaminophen 300 MG / codeine phosphate 30 MG Oral Tablet

Clinical Specifications

Proprietary Name
Acetaminophen And Codeine Phosphate
Non-Proprietary Name
Acetaminophen And Codeine Phosphate
Substance Name
Acetaminophen; Codeine Phosphate
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Acetaminophen and codeine phosphate tablets are 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 tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]Have not provided adequate analgesia, or are not expected to provide adequate analgesia,Have not been tolerated, or are not expected to be tolerated.
DEA Schedule
Schedule III (CIII) Substances

Regulatory & Marketing

Labeler Name
Elite Laboratories, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA212418
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
09-10-2019
Listing Expiration
12-31-2026
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 (64850-643). Click a package code to view its specific billing and regulatory data.

64850-643-05
500 TABLET in 1 BOTTLE
64850-643-12
120 TABLET 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 64850-643-01 identifies a specific commercial package of 100 tablet in 1 bottle of Acetaminophen And Codeine Phosphate, a human prescription drug labeled by Elite Laboratories, Inc.. This tablet 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 Elite Laboratories, Inc. on September 10, 2019. The current certification is valid through December 31, 2026.

How is this Elite Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 64850064301. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
64850-643-01
11-Digit CMS (5-4-2)
64850-0643-01

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