68135-300 : Kuvan 100 mg Oral Tablet for 4-8 Oz Oral Solution
| NDC: | 68135-300 |
| Labeler: | Biomarin Pharmaceutical Inc. |
| Product Type: | Human Prescription Drug |
| Drug Name: |  Kuvan |
| Dosage Form: | Oral Tablet |
| Application #: | NDA022181 |
| Rev. Date: |
Appearance:
| Markings: | 177 |
| Shapes: |
Round |
| Colors: |
 White |
| Size (mm): | 10 |
| 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:
- 68135-300-02: 120 TABLET IN 1 BOTTLE (68135‑300‑02)
Active Ingredients:
- Sapropterin Dihydrochloride
Dosage Strength:
- 100 mg
Inactive Ingredients:
- Ascorbic Acid
- Crospovidone
- Calcium Phosphate, Dibasic, Anhydrous
- Mannitol
- Riboflavin
- Sodium Stearyl Fumarate
Pharmaceutical Classes:
- Phenylalanine Hydroxylase Activator [EPC]
- Phenylalanine Hydroxylase Activators [MoA]
- Breast Cancer Resistance Protein Inhibitors [MoA]
- P-Glycoprotein Inhibitors [MoA]
Related Products:
Based on records with the same trade name.- 68135-301 Kuvan 100 mg/1 Oral Powder, for Solution by Biomarin Pharmaceutical Inc.
- 68135-482 Kuvan 500 mg Oral Powder, for Solution by Biomarin Pharmaceutical Inc.
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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.