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NDC 00052-0603-02 BCG VACCINE 50 mg/1 Details
BCG VACCINE 50 mg/1
BCG VACCINE is a PERCUTANEOUS INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in the VACCINE category. It is labeled and distributed by Merck Sharp & Dohme LLC. The primary component is BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN.
MedlinePlus Drug Summary
WHY is this medicine prescribed? BCG vaccine provides immunity or protection against tuberculosis (TB). The vaccine may be given to persons at high risk of developing TB. It is also used to treat bladder tumors or bladder cancer. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
Related Packages: 00052-0603-02Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Bacillus Calmette-Guerin (BCG) Vaccine
Product Information
NDC | 00052-0603 |
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Product ID | 0052-0603_1859426f-1c17-4e9c-8ebe-28e1be203344 |
Associated GPIs | 17200010002150 |
GCN Sequence Number | 066602 |
GCN Sequence Number Description | BCG vaccine, live/PF VIAL 50 MG INJECTION |
HIC3 | W7N |
HIC3 Description | TOXIN-PRODUCING BACILLI VACCINES/TOXOIDS |
GCN | 28924 |
HICL Sequence Number | 037122 |
HICL Sequence Number Description | BCG VACCINE, LIVE/PF |
Brand/Generic | Generic |
Proprietary Name | BCG VACCINE |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN |
Product Type | VACCINE |
Dosage Form | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION |
Route | PERCUTANEOUS |
Active Ingredient Strength | 50 |
Active Ingredient Units | mg/1 |
Substance Name | BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN |
Labeler Name | Merck Sharp & Dohme LLC |
Pharmaceutical Class | 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 Vac |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA103050 |
Listing Certified Through | 2024-12-31 |
Package
NDC 00052-0603-02 (00052060302)
NDC Package Code | 0052-0603-02 |
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Billing NDC | 00052060302 |
Package | 1 VIAL in 1 CARTON (0052-0603-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0052-0603-01) |
Marketing Start Date | 1989-06-21 |
NDC Exclude Flag | N |
Pricing Information | N/A |