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  4. NDC Product Code: 0054-0843 Hydrocodone Bitartrate And Acetaminophen

NDC 0054-0843 Hydrocodone Bitartrate And Acetaminophen

Liquid Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0054-0843?
  5. Hydrocodone Bitartrate And Acetaminophen Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

Get all the details for National Drug Code (NDC) 0054-0843 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
0054-0843
Proprietary Name:
Hydrocodone Bitartrate And Acetaminophen
Non-Proprietary Name: [1]
Hydrocodone Bitartrate And Acetaminophen
Substance Name: [2]
Acetaminophen; Hydrocodone Bitartrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
Oral - Administration to or by way of the mouth.
Labeler Name: [5]
Hikma Pharmaceuticals Usa Inc.
Labeler Code:
0054
Product Label ID:
995a6cc7-8b72-4d35-b3b4-8c5752438fb7
FDA Application Number: [6]
ANDA040881
DEA Schedule: [7]
Schedule II (CII) Substances
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
06-02-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Navigator:

Product Characteristics

Flavor(s):
FRUIT PUNCH (C73390)

Code Structure Chart

Product Details

What is NDC 0054-0843?

The NDC code 0054-0843 is assigned by the FDA to the product Hydrocodone Bitartrate And Acetaminophen which is a human prescription drug product labeled by Hikma Pharmaceuticals Usa Inc.. The product's dosage form is liquid and is administered via oral form. The product is distributed in a single package with assigned NDC code 0054-0843-63 473 ml in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Hydrocodone Bitartrate And Acetaminophen?

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.

What are Hydrocodone Bitartrate And Acetaminophen Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ACETAMINOPHEN 300 mg/15mL - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
  • HYDROCODONE BITARTRATE 10 mg/15mL - Narcotic analgesic related to CODEINE, but more potent and more addicting by weight. It is used also as cough suppressant.

Which are Hydrocodone Bitartrate And Acetaminophen UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Hydrocodone Bitartrate And Acetaminophen Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Hydrocodone Bitartrate And Acetaminophen?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

Which are the Pharmacologic Classes for Hydrocodone Bitartrate And Acetaminophen?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Product Footnotes

[1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

[2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

[3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[7] What is the Drug Enforcement Administration (DEA) CII Schedule? - This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".