Hydrocodone Bitartrate And Acetaminophen Liquid
NDC Package 0054-0843-63

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

Package Information

Hydrocodone Bitartrate And Acetaminophen liquids is hydrocodone bitartrate and acetaminophen oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS], reserve hydrocodone bitartrate and acetaminophen 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 analgesiaHydrocodone bitartrate and acetaminophen oral solution should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate. This formulation utilizes a liquid delivery system. Marketed by Hikma Pharmaceuticals Usa Inc., this product is identified by NDC 0054-0843 and is authorized under FDA application ANDA040881.

Identification & Billing

NDC Package Code
0054-0843-63
Package Description
473 mL in 1 BOTTLE
Product Code
0054-0843
11-Digit Billing Format
00054084363
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: 1044427 - HYDROcodone bitartrate 10 MG / acetaminophen 300 MG in 15 mL Oral Solution
  • RxCUI: 1044427 - acetaminophen 20 MG/ML / hydrocodone bitartrate 0.667 MG/ML Oral Solution
  • RxCUI: 1044427 - APAP 20 MG/ML / Hydrocodone Bitartrate 0.667 MG/ML Oral Solution
  • RxCUI: 1044427 - APAP 300 MG / hydrocodone bitartrate 10 MG per 15 ML Oral Solution

Clinical Specifications

Proprietary Name
Hydrocodone Bitartrate And Acetaminophen
Non-Proprietary Name
Hydrocodone Bitartrate And Acetaminophen
Substance Name
Acetaminophen; Hydrocodone Bitartrate
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Hydrocodone bitartrate and acetaminophen oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration [see WARNINGS], reserve hydrocodone bitartrate and acetaminophen 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 analgesiaHydrocodone bitartrate and acetaminophen oral solution should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Hikma Pharmaceuticals Usa Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA040881
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-02-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0054-0843-63 identifies a specific commercial package of 473 ml in 1 bottle of Hydrocodone Bitartrate And Acetaminophen, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 473 billable units per package. This liquid is formulated for oral use and contains acetaminophen; hydrocodone bitartrate 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 Hikma Pharmaceuticals Usa Inc. on June 02, 2025. The current certification is valid through December 31, 2027.

How is this Hikma Pharmaceuticals Usa Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00054084363. 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 (4-4-2)
0054-0843-63
11-Digit CMS (5-4-2)
00054-0843-63

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