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  4. NDC Product Code: 0052-0602 Tice Bcg

NDC 0052-0602 Tice Bcg

Bacillus Calmette-guerin Powder, For Suspension Intravesical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0052-0602?
  4. Tice Bcg Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes
  10. Patient Education

Product Information

NDC Product Code:
0052-0602
Proprietary Name:
Tice Bcg
Non-Proprietary Name: [1]
Bacillus Calmette-guerin
Substance Name: [2]
Bacillus Calmette-guerin Substrain Tice Live Antigen
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Powder, For Suspension - An intimate mixture of dry, finely divided drugs and/or chemicals, which, upon the addition of suitable vehicles, yields a suspension (a liquid preparation containing the solid particles dispersed in the liquid vehicle).
Administration Route(s): [4]
  • Intravesical - Administration within the bladder.
    • Labeler Name: [5]
    Merck Sharp & Dohme Llc
    Labeler Code:
    0052
    Product Label ID:
    c9b74876-e665-442b-87ad-b7333bc9a67a
    FDA Application Number: [6]
    BLA102821
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    08-24-1990
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0052-0602-02

    Package Description: 1 VIAL in 1 CARTON / 50 mL in 1 VIAL (0052-0602-01)

    Price per Unit: $152.80000 per EA

    Product Details

    What is NDC 0052-0602?

    The NDC code 0052-0602 is assigned by the FDA to the product Tice Bcg which is a human prescription drug product labeled by Merck Sharp & Dohme Llc. The generic name of Tice Bcg is bacillus calmette-guerin. The product's dosage form is powder, for suspension and is administered via intravesical form. The product is distributed in a single package with assigned NDC code 0052-0602-02 1 vial in 1 carton / 50 ml in 1 vial (0052-0602-01). 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 Tice Bcg?

    TICE® BCG is indicated for the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder, and for the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR). TICE BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence.TICE BCG is not indicated for papillary tumors of stages higher than T1.

    What are Tice Bcg 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.

    Which are Tice Bcg UNII Codes?

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

    • BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN (UNII: 2XQ558L16Z)
    • BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN (UNII: 2XQ558L16Z) (Active Moiety)

    Which are Tice Bcg 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 Tice Bcg?

    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:

    Which are the Pharmacologic Classes for Tice Bcg?

    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

    Bacillus Calmette-Guerin (BCG) Vaccine


    WHY is this medicine prescribed? BCG vaccine provides immunity or protection against tuberculosis (TB). The vaccine may be given to persons at high risk of developing TB. It is also used to treat bladder tumors or bladder cancer. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [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".