0052-0603 NDC - BCG VACCINE (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN)

Drug Information

Product NDC: 0052-0603

Proprietary Name: BCG VACCINE

Non Proprietary Name: BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN

Active Ingredient(s):
  • 50 mg/1 BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN


Administration Route(s): PERCUTANEOUS

Dosage Form(s): INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

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

Labeler Information

Labeler Name: Merck Sharp & Dohme Corp.
Product Type: VACCINE
FDA Application Number: BLA103050
Marketing Category: BLA
Start Marketing Date:6/21/1989

Package Information

No. Package Code Package Description Billing Unit
10052-0603-021 VIAL in 1 CARTON (0052-0603-02) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0052-0603-01)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0052-0603The 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 NAMEVACCINEIndicates 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 NAMEBCG VACCINEThe 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-GUERIN SUBSTRAIN TICE LIVE ANTIGENThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEPERCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE6/21/1989This 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 NUMBERBLA103050This 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 Corp.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEBACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGENThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH50 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESLive Attenuated Bacillus Calmette-Guerin Vaccine [EPC],Actively Acquired Immunity [PE],Vaccines, Attenuated [CS],BCG Vaccine [CS],Live Attenuated Bacillus Calmette-Guerin Immunotherapy [EPC],Increased Macrophage Proliferation [PE],Increased Immunologically Active Molecule Activity [PE] 

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This page was last updated on: 11/8/2021