INLEXZO
- Product NDC
- 57894-225
- 11-digit product format
- 578940225
- Labeler code
- 57894
- Product ID
- 57894-225_3e9075cb-001f-40f0-e063-6394a90aee94
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- gemcitabine intravesical
- Dosage form
- SYSTEM
- Route
- INTRAVESICAL
- Labeler
- Janssen Biotech, Inc
- Application
- NDA219683
- Marketing category
- NDA
- Marketing start
- 2025-09-14
- Substance
- GEMCITABINE
- Active strength
- 225 mg/1
- Pharmacologic classes
- Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- INLEXZO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GEMCITABINE | 225 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | B76N6SBZ8R |
| Rxcui | 2723386, 2723391 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57894-225-01 | INLEXZO | 1 in 1 BOX | SYSTEM | 1 | | 1 |
| 57894-225-99 | INLEXZO | 1 in 1 BOX | SYSTEM | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 57894-225-01 | 57894022501 | 1 SYSTEM in 1 BOX (57894-225-01) | 1 system | 2025-09-14 | No | No | Current |
| 57894-225-99 | 57894022599 | 1 SYSTEM in 1 BOX (57894-225-99) | 1 system | 2025-09-14 | Yes | No | Current |