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  4. NDC Product Code: 13107-004 Hydrocodone Bitartrate And Ibuprofen

NDC 13107-004 Hydrocodone Bitartrate And Ibuprofen

Tablet, Film Coated Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 13107-004?
  5. Hydrocodone Bitartrate And Ibuprofen Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
13107-004
Proprietary Name:
Hydrocodone Bitartrate And Ibuprofen
Non-Proprietary Name: [1]
Hydrocodone Bitartrate And Ibuprofen
Substance Name: [2]
Hydrocodone Bitartrate; Ibuprofen
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Aurolife Pharma, Llc
    Labeler Code:
    13107
    Product Label ID:
    470df63a-5c0f-42df-9023-a330a901153e
    FDA Application Number: [6]
    ANDA204575
    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]
    06-02-2016
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE TO OFF-WHITE)
    Shape:
    ROUND (C48348)
    Size(s):
    10 MM
    Imprint(s):
    U;13
    Score:
    1

    Product Packages

    NDC Code 13107-004-01

    Package Description: 100 TABLET, FILM COATED in 1 BOTTLE

    Price per Unit: $0.48266 per EA

    NDC Code 13107-004-05

    Package Description: 500 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 13107-004-11

    Package Description: 10 TABLET, FILM COATED in 1 BOTTLE

    NDC Code 13107-004-99

    Package Description: 1000 TABLET, FILM COATED in 1 BOTTLE

    Product Details

    What is NDC 13107-004?

    The NDC code 13107-004 is assigned by the FDA to the product Hydrocodone Bitartrate And Ibuprofen which is a human prescription drug product labeled by Aurolife Pharma, Llc. The product's dosage form is tablet, film coated and is administered via oral form. The product is distributed in 4 packages with assigned NDC codes 13107-004-01 100 tablet, film coated in 1 bottle , 13107-004-05 500 tablet, film coated in 1 bottle , 13107-004-11 10 tablet, film coated in 1 bottle , 13107-004-99 1000 tablet, film coated 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 Ibuprofen?

    Hydrocodone Bitartrate and Ibuprofen Tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseCarefully consider the potential benefits and risks of Hydrocodone Bitartrate and Ibuprofen Tablets and other treatment options before deciding to use Hydrocodone Bitartrate and Ibuprofen Tablets Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see WARNINGS: Cardiovascular Thrombotic Events, Gastrointestinal Bleeding, Ulceration, and Perforation). Do not use Hydrocodone Bitartrate and Ibuprofen Tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis.Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses (seeWARNINGS: Addiction, Abuse, and Misuse), reserve Hydrocodone Bitartrate and Ibuprofen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):•   Have not been tolerated, or are not expected to be tolerated,•   Have not provided adequate analgesia, or are not expected to provide adequate analgesia

    What are Hydrocodone Bitartrate And Ibuprofen 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.
    • HYDROCODONE BITARTRATE 7.5 mg/1 - Narcotic analgesic related to CODEINE, but more potent and more addicting by weight. It is used also as cough suppressant.
    • IBUPROFEN 200 mg/1 - A non-steroidal anti-inflammatory agent with analgesic, antipyretic, and anti-inflammatory properties

    Which are Hydrocodone Bitartrate And Ibuprofen UNII Codes?

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

    Which are Hydrocodone Bitartrate And Ibuprofen 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 Ibuprofen?

    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: 858798 - HYDROcodone bitartrate 7.5 MG / ibuprofen 200 MG Oral Tablet
    • RxCUI: 858798 - hydrocodone bitartrate 7.5 MG / ibuprofen 200 MG Oral Tablet

    Which are the Pharmacologic Classes for Hydrocodone Bitartrate And Ibuprofen?

    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.

    Patient Education

    Hydrocodone Combination Products


    Hydrocodone is available in combination with other ingredients, and different combination products are prescribed for different uses. Some hydrocodone combination products are used to relieve moderate-to-severe pain. Other hydrocodone combination products are used to relieve cough. Hydrocodone is in a class of medications called opiate (narcotic) analgesics and in a class of medications called antitussives. Hydrocodone relieves pain by changing the way the brain and nervous system respond to pain. Hydrocodone relieves cough by decreasing activity in the part of the brain that causes coughing. You will take hydrocodone in combination with at least one other medication, but this monograph only provides information about hydrocodone. Be sure to read information about the other ingredients in the hydrocodone product you are taking. Ask your doctor or pharmacist if you have any questions.
    [Learn More]


    Pain Relievers


    Pain relievers are medicines that reduce or relieve headaches, sore muscles, arthritis, or other aches and pains. There are many different pain medicines, and each one has advantages and risks. Some types of pain respond better to certain medicines than others. Each person may also have a slightly different response to a pain reliever.

    Over-the-counter (OTC) medicines are good for many types of pain. There are two main types of OTC pain medicines: acetaminophen (Tylenol) and nonsteroidal anti-inflammatory drugs (NSAIDs). Aspirin, naproxen (Aleve), and ibuprofen (Advil, Motrin) are examples of OTC NSAIDs.

    If OTC medicines don't relieve your pain, your doctor may prescribe something stronger. Many NSAIDs are also available at higher prescription doses. The most powerful pain relievers are opioids. They are very effective, but they can sometimes have serious side effects. There is also a risk of addiction. Because of the risks, you must use them only under a doctor's supervision.

    There are many things you can do to help ease pain. Pain relievers are just one part of a pain treatment plan.


    [Learn More]


    * 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".