0052-0602 NDC - TICE BCG (BACILLUS CALMETTE-GUERIN)

Drug Information

Product NDC: 0052-0602

Proprietary Name: TICE BCG

Non Proprietary Name: BACILLUS CALMETTE-GUERIN

Active Ingredient(s):
  • 50 mg/50mL BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN


Administration Route(s): INTRAVESICAL

Dosage Form(s): POWDER, FOR SUSPENSION

Pharmacy Class(es):
  • Actively Acquired Immunity [PE];
  • BCG Vaccine [CS];
  • Increased Immunologically Active Molecule Activity [PE];
  • Increased Macrophage Proliferation [PE];
  • Live Attenuated Bacillus Calmette-Guerin Immunotherapy [EPC];
  • Live Attenuated Bacillus Calmette-Guerin Vaccine [EPC];
  • Vaccines;
  • Attenuated [CS]

Labeler Information

Labeler Name: Merck Sharp & Dohme LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: BLA102821
Marketing Category: BLA
Start Marketing Date:8/24/1990

Package Information

No. Package Code Package Description Billing Unit
10052-0602-021 VIAL in 1 CARTON (0052-0602-02) > 50 mL in 1 VIAL (0052-0602-01)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0052-0602The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates 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.
PROPRIETARY NAMETICE BCGThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEBACILLUS CALMETTE-GUERINThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPOWDER, FOR SUSPENSIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEINTRAVESICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/24/1990This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEBLAProduct 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.
APPLICATION NUMBERBLA102821This 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.
LABELER NAMEMerck Sharp & Dohme LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGENThe following is the list of active ingredients in this product. 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.
ACTIVE NUMERATOR STRENGTH50 
ACTIVE INGRED UNITmg/50mL 
PHARM CLASSESActively Acquired Immunity [PE], BCG Vaccine [CS], Increased Immunologically Active Molecule Activity [PE], Increased Macrophage Proliferation [PE], Live Attenuated Bacillus Calmette-Guerin Immunotherapy [EPC], Live Attenuated Bacillus Calmette-Guerin Vaccine [EPC], Vaccines, Attenuated [CS] 

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This page was last updated on: 9/15/2022