Prescription drug · NDA
Balversa (Erdafitinib) NDC 59676-050
Erdafitinib 5 mg/1 · Tablet, Film coated · Oral · Janssen Products LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59676-050-28 | 5967600502859676005028 | 1 BOTTLE in 1 CARTON (59676-050-28) / 28 TABLET, FILM COATED in 1 BOTTLEMarketed from Apr 12, 2019 |
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)
- Balversa
- Generic name (nonproprietary)
- erdafitinib
- Active ingredients
- Erdafitinib — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Janssen Products LPNDC labeler code 59676
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 212018
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inducers (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Fibroblast Growth Factor Receptor Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 59676-050_41ec18e6-999d-f298-e063-6294a90aa2dcSPL ID 41ec18e6-999d-f298-e063-6294a90aa2dcSPL set ID 2a8aa5c0-6c92-4566-8c45-e8f4d1fc20eeRxCUI 2123131, 2123137, 2123139, 2123141, 2123143, 2123145UNII 890E37NHMV
- Pharmacologic class
- Kinase 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N459676005028followed by a unit qualifier and the quantityPackage 59676-0050-28. 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)
BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA [see Dosage and Administration (2.1) and Clinical Studies (14.1) ] . BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for thera…
Excerpt only. Read the full label for complete information.
About NDC 59676-050
- What is NDC 59676-050?
- 59676-050 is the product NDC for Balversa (erdafitinib), Erdafitinib 5 mg/1 tablet, film coated, listed with the FDA by Janssen Products LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Balversa (Erdafitinib).
- What is the active ingredient?
- Erdafitinib.
- Who is the labeler?
- Janssen Products LP, NDC labeler code 59676. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Balversa?
- 2 other product NDCs are listed under this name. See all Balversa NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Balversa products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Balversaerdafitinib | Erdafitinib 3 mg/1 | Tablet, Film coatedOral | Janssen Products LP | 59676-030 | 59676-0030-5659676-0030-84 |
| Balversaerdafitinib | Erdafitinib 4 mg/1 | Tablet, Film coatedOral | Janssen Products LP | 59676-040 | 59676-0040-2859676-0040-56 |
Other NDCs under NDA 212018
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Balversaerdafitinib | Erdafitinib 3 mg/1 | Tablet, Film coatedOral | Janssen Products LP | 59676-030 |
| Balversaerdafitinib | Erdafitinib 4 mg/1 | Tablet, Film coatedOral | Janssen Products LP | 59676-040 |