NDC 13107-060 Acetaminophen And Codeine Phosphate

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

Product Information

NDC Product Code:
13107-060
Proprietary Name:
Acetaminophen And Codeine Phosphate
Non-Proprietary Name: [1]
Acetaminophen And Codeine Phosphate
Substance Name: [2]
Acetaminophen; Codeine Phosphate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
  • Labeler Name: [5]
    Aurolife Pharma, Llc
    Labeler Code:
    13107
    FDA Application Number: [6]
    ANDA202800
    DEA Schedule: [7]
    Schedule III (CIII) Substances
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    04-15-2013
    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):
    11 MM
    Imprint(s):
    U35
    U36
    U37
    Score:
    1

    Product Packages

    NDC Code 13107-060-01

    Package Description: 100 TABLET in 1 BOTTLE

    Price per Unit: $0.44829 per EA

    NDC Code 13107-060-05

    Package Description: 500 TABLET in 1 BOTTLE

    Price per Unit: $0.44829 per EA

    NDC Code 13107-060-30

    Package Description: 30 TABLET in 1 BOTTLE

    NDC Code 13107-060-99

    Package Description: 1000 TABLET in 1 BOTTLE

    Price per Unit: $0.44829 per EA

    Product Details

    What is NDC 13107-060?

    The NDC code 13107-060 is assigned by the FDA to the product Acetaminophen And Codeine Phosphate which is a human prescription drug product labeled by Aurolife Pharma, Llc. The product's dosage form is tablet and is administered via oral form. The product is distributed in 4 packages with assigned NDC codes 13107-060-01 100 tablet in 1 bottle , 13107-060-05 500 tablet in 1 bottle , 13107-060-30 30 tablet in 1 bottle , 13107-060-99 1000 tablet 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 Acetaminophen And Codeine Phosphate?

    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 analgesiaHave not been tolerated, or are not expected to be tolerated

    What are Acetaminophen And Codeine Phosphate 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/1 - 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.
    • CODEINE PHOSPHATE 60 mg/1 - An opioid analgesic related to MORPHINE but with less potent analgesic properties and mild sedative effects. It also acts centrally to suppress cough.

    Which are Acetaminophen And Codeine Phosphate UNII Codes?

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

    Which are Acetaminophen And Codeine Phosphate 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 Acetaminophen And Codeine Phosphate?

    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: 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

    Which are the Pharmacologic Classes for Acetaminophen And Codeine Phosphate?

    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

    Acetaminophen and Codeine


    The combination of acetaminophen and codeine is used to relieve mild to moderate pain. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body. Codeine belongs to a class of medications called opiate (narcotic) analgesics and to a class of medications called antitussives. When codeine is used to treat pain, it works by changing the way the brain and nervous system respond to pain. When codeine is used to reduce coughing, it works by decreasing the activity in the part of the brain that causes coughing.
    [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) CIII 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".