Bcg Vaccine Injection, Powder, Lyophilized, For Solution
NDC Package 0052-0603-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Bcg Vaccine (bacillus calmette-guerin substrain tice live antigen) injection is bCG VACCINE (TICE® strain) is indicated for the prevention of tuberculosis in persons not previously infected with M. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Merck Sharp & Dohme Llc, this product is identified by NDC 0052-0603 and is authorized under FDA application BLA103050.

Identification & Billing

NDC Package Code
0052-0603-02
Package Description
1 VIAL in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0052-0603-01)
Product Code
0052-0603
11-Digit Billing Format
00052060302
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bcg Vaccine
Non-Proprietary Name
Bacillus Calmette-guerin Substrain Tice Live Antigen
Substance Name
Bacillus Calmette-guerin Substrain Tice Live Antigen
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Percutaneous - Administration through the skin.
Active Ingredient(s)
BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN 50 mg/1
Pharmacologic Class
Usage Information
BCG VACCINE (TICE® strain) is indicated for the prevention of tuberculosis in persons not previously infected with M. tuberculosis who are at high risk for exposure. As with any vaccine, immunization with BCG VACCINE may not protect 100% of susceptible individuals.The Advisory Committee on Immunization Practices (ACIP) and the Advisory Committee for the Elimination of Tuberculosis has recommended that BCG vaccination be considered in the following circumstances.{3}

Regulatory & Marketing

Labeler Name
Merck Sharp & Dohme Llc
Product Type
Vaccine
FDA Application #
BLA103050
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-21-1989
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0052-0603-02 identifies a specific commercial package of 1 vial in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial (0052-0603-01) of Bcg Vaccine, a vaccine label labeled by Merck Sharp & Dohme Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for percutaneous use and contains bacillus calmette-guerin substrain tice live antigen as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Merck Sharp & Dohme Llc on June 21, 1989. The current certification is valid through December 31, 2026.

How is this Merck Sharp & Dohme Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00052060302. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0052-0603-02
11-Digit CMS (5-4-2)
00052-0603-02

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.