NDC 68382-260 Ribavirin

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

Product Information

NDC Product Code:
68382-260
Proprietary Name:
Ribavirin
Non-Proprietary Name: [1]
Ribavirin
Substance Name: [2]
Ribavirin
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]
    Zydus Pharmaceuticals Usa Inc.
    Labeler Code:
    68382
    FDA Application Number: [6]
    ANDA077224
    Marketing Category: [8]
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date: [9]
    01-25-2006
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    WHITE (C48325 - WHITE)
    Shape:
    CAPSULE (C48336)
    Size(s):
    22 MM
    Imprint(s):
    ZA;12;200MG
    Score:
    1

    Product Packages

    NDC Code 68382-260-03

    Package Description: 168 CAPSULE in 1 BOTTLE

    NDC Code 68382-260-04

    Package Description: 42 CAPSULE in 1 BOTTLE

    Price per Unit: $1.27548 per EA

    NDC Code 68382-260-07

    Package Description: 56 CAPSULE in 1 BOTTLE

    Price per Unit: $1.27548 per EA

    NDC Code 68382-260-09

    Package Description: 70 CAPSULE in 1 BOTTLE

    Price per Unit: $1.27548 per EA

    NDC Code 68382-260-10

    Package Description: 1000 CAPSULE in 1 BOTTLE

    NDC Code 68382-260-12

    Package Description: 84 CAPSULE in 1 BOTTLE

    Price per Unit: $1.27548 per EA

    NDC Code 68382-260-13

    Package Description: 140 CAPSULE in 1 BOTTLE

    NDC Code 68382-260-28

    Package Description: 180 CAPSULE in 1 BOTTLE

    NDC Code 68382-260-77

    Package Description: 100 BLISTER PACK in 1 CARTON / 1 CAPSULE in 1 BLISTER PACK (68382-260-30)

    Product Details

    What is NDC 68382-260?

    The NDC code 68382-260 is assigned by the FDA to the product Ribavirin which is a human prescription drug product labeled by Zydus Pharmaceuticals Usa Inc.. The product's dosage form is capsule and is administered via oral form. The product is distributed in 9 packages with assigned NDC codes 68382-260-03 168 capsule in 1 bottle , 68382-260-04 42 capsule in 1 bottle , 68382-260-07 56 capsule in 1 bottle , 68382-260-09 70 capsule in 1 bottle , 68382-260-10 1000 capsule in 1 bottle , 68382-260-12 84 capsule in 1 bottle , 68382-260-13 140 capsule in 1 bottle , 68382-260-28 180 capsule in 1 bottle , 68382-260-77 100 blister pack in 1 carton / 1 capsule in 1 blister pack (68382-260-30). 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 Ribavirin?

    Ribavirin is used in combination with other antiviral medications (such as interferon, sofosbuvir) to treat chronic (long-lasting) hepatitis C, a viral infection of the liver. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer. Ribavirin works by reducing the amount of hepatitis C virus in your body, which may help your liver recover. It is not known if this treatment can prevent you from passing the virus to others. Do not share needles, and practice "safer sex" (including the use of latex condoms) to lower the risk of passing the virus to others.

    What are Ribavirin 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.
    • RIBAVIRIN 200 mg/1 - A nucleoside antimetabolite antiviral agent that blocks nucleic acid synthesis and is used against both RNA and DNA viruses.

    Which are Ribavirin UNII Codes?

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

    Which are Ribavirin 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 Ribavirin?

    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 code indicates a single concept unique identifier (RXCUI) is associated with this product:

    Which are the Pharmacologic Classes for Ribavirin?

    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

    Ribavirin


    Ribavirin is used with an interferon medication such as peginterferon alfa-2a [Pegasys] or peginterferon alpha-2b [PEG-Intron]) to treat hepatitis C in people who have not been treated with an interferon before. Ribavirin is in a class of antiviral medications called nucleoside analogues. It works by stopping the virus that causes hepatitis C from spreading inside the body. It is not known if treatment that includes ribavirin and another medication cures hepatitis C infection, prevents liver damage that may be caused by hepatitis C, or prevents the spread of hepatitis C to other people.
    [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.

    [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".