Prescription drug · NDA
Inlexzo (Gemcitabine intravesical) NDC 57894-225
Gemcitabine 225 mg/1 · System · Intravesical · Janssen Biotech, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57894-225-01 | 57894022501 | 1 SYSTEM in 1 BOX (57894-225-01)Marketed from Sep 14, 2025 | |
| 57894-225-99 | 57894022599 | 1 SYSTEM in 1 BOX (57894-225-99)Marketed from Sep 14, 2025 · Sample package |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Inlexzo
- Generic name (nonproprietary)
- gemcitabine intravesical
- Active ingredients
- Gemcitabine — 225 mg/1
- Dosage form
- System
- Route
- Intravesical
- Labeler
- Janssen Biotech, IncNDC labeler code 57894
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219683
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 57894-225_3e9075cb-001f-40f0-e063-6394a90aee94SPL ID 3e9075cb-001f-40f0-e063-6394a90aee94SPL set ID 3aef8dbc-34d0-4150-89f0-3b16cf0fbfdbRxCUI 2723386, 2723391UNII B76N6SBZ8R
- Pharmacologic class
- Nucleoside Metabolic Inhibitor
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.
- NDC on a medical claim
N457894022501followed by a unit qualifier and the quantityPackage 57894-0225-01. 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 .
Indications (excerpt from the label)
INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. INLEXZO is a nucleoside metabolic inhibitor-containing intravesical system, indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 57894-225
- What is NDC 57894-225?
- 57894-225 is the product NDC for Inlexzo (gemcitabine intravesical), Gemcitabine 225 mg/1 system, listed with the FDA by Janssen Biotech, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Inlexzo (Gemcitabine intravesical).
- What is the active ingredient?
- Gemcitabine.
- Who is the labeler?
- Janssen Biotech, Inc, NDC labeler code 57894. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Inlexzo?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.