Quick answers
- What is Bacillus calmette-guerin used for?
- The FDA-approved label (Tice Bcg, Merck Sharp & Dohme LLC, February 20, 2026) says: “TICE ® BCG is indicated for: the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR) Limitations of Use: TICE BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Bacillus calmette-guerin have a boxed warning?
- Yes. The FDA label for Tice Bcg has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Bacillus calmette-guerin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Bacillus calmette-guerin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Bacillus calmette-guerin?
- 1 company lists prescription products of Bacillus calmette-guerin in the FDA NDC Directory, including Merck Sharp & Dohme LLC.
What Bacillus calmette-guerin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
TICE ® BCG is indicated for: the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR) Limitations of Use: TICE BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence. …
— FDA label: Tice Bcg, Merck Sharp & Dohme LLC, effective February 20, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
Forms and how it is given
| Dosage forms | Powder, for suspension |
|---|---|
| Route | Intravesical |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Tice Bcg |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| bacillus calmette-guerin substrain tice live antigen 50 mg/50 mL powder, for suspension | Brand: Tice Bcg | $187.77 per unit |
NADAC list of November 4, 2026; these prices took effect on September 26, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Merck Sharp & Dohme LLC1 product
FDA approval history
- BLA: Biologics License Application: how a biologic medicine (made from living cells) is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| BLA102821 | — | Date not on file | — |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 213744, 1653484 |
|---|---|
| SPL set ID of the quoted label | c9b74876-e665-442b-87ad-b7333bc9a67a |
| FDA labels (SPL) | 1 |
| FDA applications | BLA102821 |
| Active ingredients (FDA) | BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Tice Bcg, Merck Sharp & Dohme LLC, effective February 20, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →