NDC codes

FDA NDC Directory
Product NDC (as listed)0052-0602Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00052-0602Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0052-0602-02000520602021 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 antigen50 mg/50mL
Dosage form
Powder, For suspension
Route
Intravesical
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.

How CPT relates to drug billing

NDC on a medical claim

N400052060202 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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