United States· US:0052-0603_2080f9b5-aac4-4fd1-b8aa-a7862fe28947

BCG VACCINE

A medicinal product containing bacillus calmette-guerin substrain tice live antigen, registered in United States by Merck Sharp & Dohme LLC.

US label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedBCG VACCINEATC—REGISTER NO.US:0052-0603_2080f9b5…PACKS LISTED2CHECKEDSeptember 27, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN
Manufacturer
Merck Sharp & Dohme LLC
Country
United States (US)
ATC code
—
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
September 27, 2026

Packs & prices · 2

  • ndc11
    0052060302
    1 VIAL in 1 CARTON (0052-0603-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (0052-0603-01)
  • ndc11
    0052-0603-02

Regulatory notes

No shortage, Orange Book or US label notes for this record.

Same medicine, other countries

Bacillus calmette-guerin substrain tice live antigen in 1 other country

What each register calls a product with the same active substance — salts and hydrates count as the same.

All bacillus calmette-guerin substrain tice live antigen products

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/be39d58e-22a7-44d5-bf84-faa363a6c426
GET /v1/drugs/be39d58e-22a7-44d5-bf84-faa363a6c426?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "route": "PERCUTANEOUS",
  "source": "ndc",
  "strength": "50",
  "substance": "BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN",
  "productndc": "0052-0603",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "dea_schedule": null,
  "strength_unit": "mg/1",
  "application_number": "BLA103050",
  "marketing_category": "BLA"
}

See everything about bacillus calmette-guerin substrain tice live antigen.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.