NDC 0052-0602

TICE BCG

Bacillus Calmette-guerin

TICE BCG is a Intravesical Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Bacillus Calmette-guerin Substrain Tice Live Antigen.

Product ID0052-0602_15b47e92-12ad-4829-a163-21e527009a77
NDC0052-0602
Product TypeHuman Prescription Drug
Proprietary NameTICE BCG
Generic NameBacillus Calmette-guerin
Dosage FormPowder, For Suspension
Route of AdministrationINTRAVESICAL
Marketing Start Date1990-08-24
Marketing CategoryBLA / BLA
Application NumberBLA102821
Labeler NameMerck Sharp & Dohme Corp.
Substance NameBACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN
Active Ingredient Strength50 mg/50mL
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]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0052-0602-02

1 VIAL in 1 CARTON (0052-0602-02) > 50 mL in 1 VIAL (0052-0602-01)
Marketing Start Date1990-08-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0052-0602-02 [00052060202]

TICE BCG POWDER, FOR SUSPENSION
Marketing CategoryBLA
Application NumberBLA102821
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1990-08-24

NDC 0052-0602-01 [00052060201]

TICE BCG POWDER, FOR SUSPENSION
Marketing CategoryBLA
Application NumberBLA102821
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-11-21

Drug Details

Active Ingredients

IngredientStrength
BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN50 mg/50mL

OpenFDA Data

SPL SET ID:c9b74876-e665-442b-87ad-b7333bc9a67a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1653484
  • 213744
  • Pharmacological Class

    • 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]

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