Prescription drug · BLA
Tice Bcg (bacillus calmette-guerin) NDC 0052-0602
Bacillus calmette-guerin substrain tice live antigen 50 mg/50mL · Powder, For suspension · Intravesical · Merck Sharp & Dohme LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0052-0602-02 | 00052060202 | 1 VIAL in 1 CARTON (0052-0602-02) / 50 mL in 1 VIAL (0052-0602-01)Marketed from Aug 24, 1990 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Tice Bcg
- Generic name (nonproprietary)
- bacillus calmette-guerin
- Active ingredients
- Bacillus calmette-guerin substrain tice live antigen — 50 mg/50mL
- Dosage form
- Powder, For suspension
- Route
- Intravesical
- Labeler
- Merck Sharp & Dohme LLC
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 102821
- Marketing start
- Listing expires
- Other FDA classes
- Actively Acquired Immunity (Physiologic effect)BCG Vaccine (Chemical structure)Increased Immunologically Active Molecule Activity (Physiologic effect)Increased Macrophage Proliferation (Physiologic effect)Attenuated (Chemical structure)
- Identifiers
- Product ID 0052-0602_223f2b2b-87d0-4beb-b00a-16a2b041a5bcSPL ID 223f2b2b-87d0-4beb-b00a-16a2b041a5bcSPL set ID c9b74876-e665-442b-87ad-b7333bc9a67aRxCUI 213744, 1653484UNII 2XQ558L16ZUPC 0300520602020
- Pharmacologic class
- Live Attenuated Bacillus Calmette-Guerin Immunotherapy; Live Attenuated Bacillus Calmette-Guerin Vaccine
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Immunization administration (CPT 90460–90474)
Giving a vaccine is reported separately from the vaccine product code, with an immunization administration code. Which code applies depends on the patient's age, the route and whether counselling was provided.
- NDC on a medical claim
N400052060202followed by a unit qualifier and the quantityPackage 00052-0602-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE 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. TICE BCG is not indicated for papillary tumors of stages higher than T1.
Excerpt only. Read the full label for complete information.