51862-462 : Tolsura 65 mg Oral Capsule, Gelatin Coated
| NDC: | 51862-462 |
| Labeler: | Mayne Pharma Inc. |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Tolsura |
| Dosage Form: | Oral Capsule, Gelatin Coated |
| Application #: | NDA208901 |
| Rev. Date: |
Appearance:
| Markings: | i;65 |
| Shapes: |
Capsule |
| Colors: |
 Blue /
 White |
| Size (mm): | 19 |
| 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:
- 51862-462-08: 8 CAPSULE, GELATIN COATED IN 1 BOTTLE, PLASTIC (51862‑462‑08)
- 51862-462-60: 60 CAPSULE, GELATIN COATED IN 1 BOTTLE, PLASTIC (51862‑462‑60)
- 51862-462-88: 8 CAPSULE, GELATIN COATED IN 1 BOTTLE, PLASTIC (51862‑462‑88)
Active Ingredients:
- Itraconazole
Dosage Strength:
- 65 mg
Inactive Ingredients:
- Hypromellose Phthalate (24% Phthalate, 55 Cst)
- Sodium Starch Glycolate Type a Potato
- Silicon Dioxide
- Magnesium Stearate
- Methylene Chloride
- Fd&c Blue No. 1
- Titanium Dioxide
- Gelatin, Unspecified /
Pharmaceutical Classes:
- Azole Antifungal [EPC]
- Azoles [CS]
- Cytochrome P450 3A4 Inhibitors [MoA]
- P-Glycoprotein Inhibitors [MoA]
- Breast Cancer Resistance Protein Inhibitors [MoA]
NDC QR Code
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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.