59676-050 : Balversa 5 mg Oral Tablet, Film Coated
| NDC: | 59676-050 |
| Labeler: | Janssen Products Lp |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Balversa |
| Dosage Form: | Oral Tablet, Film Coated |
| Application #: | NDA212018 |
| Rev. Date: |
Appearance:
| Markings: | 5;EF |
| Shapes: |
Oval |
| Colors: |
 Brown |
| Size (mm): | 9 |
| Segments: * | 1 |
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines. | |
NDC Package Codes:
- 59676-050-28: 1 BOTTLE IN 1 CARTON (59676‑050‑28) > 28 TABLET, FILM COATED IN 1 BOTTLE
Active Ingredients:
- Erdafitinib
Dosage Strength:
- 5 mg
Inactive Ingredients:
- Croscarmellose Sodium
- Magnesium Stearate
- Mannitol
- Meglumine
- Microcrystalline Cellulose
- Glyceryl Monocaprylocaprate
- Polyvinyl Alcohol, Unspecified
- Sodium Lauryl Sulfate
- Talc
- Titanium Dioxide
- Ferric Oxide Yellow
- Ferric Oxide Red
- Ferrosoferric Oxide /
Pharmaceutical 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]
Related Products:
Based on records with the same trade name.- 59676-030 Balversa 3 mg Oral Tablet, Film Coated by Janssen Products Lp
- 59676-040 Balversa 4 mg Oral Tablet, Film Coated by Janssen Products Lp
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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.