Vaccine Information: BCG VACCINE (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — Vial Carton

NDC 0052-0603-02

BCG VACCINE

(for Percutaneous Use)

Rx only

Single-Dose Vial

PRINCIPAL DISPLAY PANEL -- Vial Carton
(click image for full-size original)
BCG VACCINE
bacillus calmette-guerin substrain tice live antigen injection, powder, lyophilized, for solution
Product Information
Product Type VACCINE Item Code (Source) NDC:0052-0603
Route of Administration PERCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN (BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN) BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN 50 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE, UNSPECIFIED FORM
Water
glycerin
asparagine
citric acid monohydrate
potassium phosphate, unspecified form
MAGNESIUM SULFATE, UNSPECIFIED FORM
ferric ammonium citrate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0052-0603-02 1 VIAL in 1 CARTON contains a VIAL (0052-0603-01)
1 NDC:0052-0603-01 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL This package is contained within the CARTON (0052-0603-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA103050 06/21/1989
Labeler — Organon USA Inc. (078796541)
Establishment
Name Address ID/FEI Operations
Organon Teknika Corporation LLC 079233640 API MANUFACTURE, MANUFACTURE
Establishment
Name Address ID/FEI Operations
Merck Sharp & Dohme Corp. 101740835 PACK

Revised: 09/2020 Organon USA Inc.

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