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  5. NDC Package Code: 0054-0843-63 Hydrocodone Bitartrate And Acetaminophen

NDC Package 0054-0843-63 Hydrocodone Bitartrate And Acetaminophen

Liquid Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

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:
0054-0843-63
Package Description:
473 mL in 1 BOTTLE
Product Code:
0054-0843
Proprietary Name:
Hydrocodone Bitartrate And Acetaminophen
Non-Proprietary Name:
Hydrocodone Bitartrate And Acetaminophen
Substance Name:
Acetaminophen; Hydrocodone Bitartrate
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.
11-Digit NDC Billing Format:
00054084363
NDC to 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
Product Type:
Human Prescription Drug
Labeler Name:
Hikma Pharmaceuticals Usa Inc.
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(s):
Oral - Administration to or by way of the mouth.
Active Ingredient(s):
Pharmacologic Class(es):
DEA Schedule:
Schedule II (CII) Substances
Sample Package:
No
FDA Application Number:
ANDA040881
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-02-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

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 0054-0843-63?

The NDC Packaged Code 0054-0843-63 is assigned to a package of 473 ml in 1 bottle of Hydrocodone Bitartrate And Acetaminophen, a human prescription drug labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is liquid and is administered via oral form.

Is NDC 0054-0843 included in the NDC Directory?

Yes, Hydrocodone Bitartrate And Acetaminophen with product code 0054-0843 is active and included in the NDC Directory. The product was first marketed by Hikma Pharmaceuticals Usa Inc. on June 02, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 0054-0843-63?

The 11-digit format is 00054084363. 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 4-4-2 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 Format10-Digit Original Code11-Digit Format11-Digit Code
4-4-20054-0843-635-4-200054-0843-63