BALVERSA
- Product NDC
- 59676-040
- 11-digit product format
- 596760040
- Labeler code
- 59676
- Product ID
- 59676-040_41ec18e6-999d-f298-e063-6294a90aa2dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Erdafitinib
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Janssen Products LP
- Application
- NDA212018
- Marketing category
- NDA
- Marketing start
- 2019-04-12
- Substance
- ERDAFITINIB
- Active strength
- 4 mg/1
- Pharmacologic classes
- Cytochrome P450 3A4 Inducers [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Fibroblast Growth Factor Receptor Inhibitors [MoA], Kinase Inhibitor [EPC], Organic Cation Transporter 2 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BALVERSA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ERDAFITINIB | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 890E37NHMV |
| Rxcui | 2123131, 2123137, 2123139, 2123141, 2123143, 2123145 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59676-040-28 | BALVERSA | 28 in 1 BOTTLE | TABLET, FILM COATED | 28 | | 14 |
| 59676-040-28 | BALVERSA | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 14 |
| 59676-040-56 | BALVERSA | 1 in 1 CARTON | TABLET, FILM COATED | 1 | | 14 |
| 59676-040-56 | BALVERSA | 56 in 1 BOTTLE | TABLET, FILM COATED | 56 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59676-040 | BALVERSA (ERDAFITINIB) TABLET, FILM COATED [JANSSEN PRODUCTS LP] | 13 | Current NDC, Legacy NDC, 4 package rows | 20241114_2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59676-040-28 | 59676004028 | 1 BOTTLE in 1 CARTON (59676-040-28) / 28 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2019-04-12 | 0000-00-00 | No | No | Current |
| 59676-040-56 | 59676004056 | 1 BOTTLE in 1 CARTON (59676-040-56) / 56 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2019-04-12 | 0000-00-00 | No | No | Current |