NDC 0904-7009 Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate

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

Product Information

NDC Product Code:
0904-7009
Proprietary Name:
Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate
Non-Proprietary Name: [1]
Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate
Substance Name: [2]
Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate
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]
  • Sublingual - Administration beneath the tongue.
  • Labeler Name: [5]
    Major Pharmaceuticals
    Labeler Code:
    0904
    FDA Application Number: [6]
    ANDA203326
    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]
    06-27-2014
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0904-7009-06

    Package Description: 50 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK

    Price per Unit: $0.53821 per EA

    Product Details

    What is NDC 0904-7009?

    The NDC code 0904-7009 is assigned by the FDA to the product Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate which is a human prescription drug product labeled by Major Pharmaceuticals. The product's dosage form is tablet and is administered via sublingual form. The product is distributed in a single package with assigned NDC code 0904-7009-06 50 blister pack in 1 carton / 1 tablet in 1 blister pack. 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 Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate?

    Buprenorphine and Naloxone Sublingual Tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and Naloxone Sublingual Tablets should be used as part of a complete treatment plan to include counseling and psychosocial support.

    What are Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate 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.
    • BUPRENORPHINE HYDROCHLORIDE 2 mg/1 - A derivative of the opioid alkaloid THEBAINE that is a more potent and longer lasting analgesic than MORPHINE. It appears to act as a partial agonist at mu and kappa opioid receptors and as an antagonist at delta receptors. The lack of delta-agonist activity has been suggested to account for the observation that buprenorphine tolerance may not develop with chronic use.
    • NALOXONE HYDROCHLORIDE DIHYDRATE .5 mg/1

    What is the NDC to RxNorm Crosswalk for Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate?

    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: 351266 - buprenorphine HCl 2 MG / naloxone HCl 0.5 MG Sublingual Tablet
    • RxCUI: 351266 - buprenorphine 2 MG / naloxone 0.5 MG Sublingual Tablet
    • RxCUI: 351266 - buprenorphine 2 MG (as buprenorphine HCl) / naloxone 0.5 MG (as naloxone HCl) Sublingual Tablet
    • RxCUI: 351267 - buprenorphine HCl 8 MG / naloxone HCl 2 MG Sublingual Tablet
    • RxCUI: 351267 - buprenorphine 8 MG / naloxone 2 MG Sublingual Tablet

    Which are the Pharmacologic Classes for Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate?

    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

    Buprenorphine Sublingual and Buccal (opioid dependence)


    Buprenorphine and the combination of buprenorphine and naloxone are used to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers). Buprenorphine is in a class of medications called opioid partial agonist-antagonists and naloxone is in a class of medications called opioid antagonists. Buprenorphine alone and the combination of buprenorphine and naloxone work to prevent withdrawal symptoms when someone stops taking opioid drugs by producing similar effects to these drugs.
    [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".