NDC 0052-0603

BCG VACCINE

Bacillus Calmette-guerin Substrain Tice Live Antigen

BCG VACCINE is a Percutaneous Injection, Powder, Lyophilized, For Solution in the Vaccine category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Bacillus Calmette-guerin Substrain Tice Live Antigen.

Product ID0052-0603_0417ae29-951b-48bb-a877-44223882d15f
NDC0052-0603
Product TypeVaccine
Proprietary NameBCG VACCINE
Generic NameBacillus Calmette-guerin Substrain Tice Live Antigen
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationPERCUTANEOUS
Marketing Start Date1989-06-21
Marketing CategoryBLA / BLA
Application NumberBLA103050
Labeler NameMerck Sharp & Dohme Corp.
Substance NameBACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN
Active Ingredient Strength50 mg/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]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0052-0603-02

1 VIAL in 1 CARTON (0052-0603-02) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0052-0603-01)
Marketing Start Date1989-06-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0052-0603-02 [00052060302]

BCG Vaccine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA103050
Product TypeVACCINE
Billing UnitEA
Marketing Start Date1989-06-21

NDC 0052-0603-01 [00052060301]

BCG Vaccine INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA103050
Product TypeVACCINE
Billing UnitEA
Marketing Start Date2013-03-07

Drug Details

Active Ingredients

IngredientStrength
BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN50 mg/1

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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