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NDC 63187-705 Trezix

Acetaminophen,Caffeine,Dihydrocodeine Bitartrate Capsule Oral - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 63187-705?
  5. Trezix Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes

Product Information

NDC Product Code:
63187-705
Proprietary Name:
Trezix
Non-Proprietary Name: [1]
Acetaminophen, Caffeine, Dihydrocodeine Bitartrate
Substance Name: [2]
Acetaminophen; Caffeine; Dihydrocodeine Bitartrate
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
Administration Route(s): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Proficient Rx Lp
    Labeler Code:
    63187
    Product Label ID:
    45c3c2a1-6a89-471e-b6d4-5a4cd73b987a
    FDA Application Number: [6]
    ANDA204785
    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]
    12-01-2014
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    RED (C48326)
    Shape:
    CAPSULE (C48336)
    Size(s):
    20 MM
    Imprint(s):
    TREZIX
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 63187-705?

    The NDC code 63187-705 is assigned by the FDA to the product Trezix which is a human prescription drug product labeled by Proficient Rx Lp. The generic name of Trezix is acetaminophen, caffeine, dihydrocodeine bitartrate. The product's dosage form is capsule and is administered via oral form. The product is distributed in 5 packages with assigned NDC codes 63187-705-00 100 capsule in 1 bottle , 63187-705-30 30 capsule in 1 bottle , 63187-705-60 60 capsule in 1 bottle , 63187-705-72 120 capsule in 1 bottle , 63187-705-90 90 capsule 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 Trezix?

    See also Warning section. This combination medication is used to help relieve moderate to severe pain. It contains an opioid pain reliever (dihydrocodeine), a non-opioid pain reliever (acetaminophen), and caffeine. Dihydrocodeine works in the brain to change how your body feels and responds to pain. Acetaminophen can also reduce a fever. Caffeine increases pain relief, especially for certain types of headaches.

    What are Trezix 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 320.5 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.
    • CAFFEINE 30 mg/1 - A methylxanthine naturally occurring in some beverages and also used as a pharmacological agent. Caffeine's most notable pharmacological effect is as a central nervous system stimulant, increasing alertness and producing agitation. It also relaxes SMOOTH MUSCLE, stimulates CARDIAC MUSCLE, stimulates DIURESIS, and appears to be useful in the treatment of some types of headache. Several cellular actions of caffeine have been observed, but it is not entirely clear how each contributes to its pharmacological profile. Among the most important are inhibition of cyclic nucleotide PHOSPHODIESTERASES, antagonism of ADENOSINE RECEPTORS, and modulation of intracellular calcium handling.
    • DIHYDROCODEINE BITARTRATE 16 mg/1

    Which are Trezix UNII Codes?

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

    Which are Trezix 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 Trezix?

    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: 1190201 - TREZIX 16 MG / 320.5 MG / 30 MG Oral Capsule
    • RxCUI: 1190201 - acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]
    • RxCUI: 1190201 - APAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]
    • RxCUI: 1190201 - Trezix (acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG) Oral Capsule
    • RxCUI: 1596108 - acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule

    Which are the Pharmacologic Classes for Trezix?

    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) 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".