Search by Drug Name or NDC
NDC 42799-0709-15 Yargesa 100 mg/1 Details
Yargesa 100 mg/1
Yargesa is a ORAL CAPSULE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Edenbridge Pharmaceuticals LLC.. The primary component is MIGLUSTAT.
MedlinePlus Drug Summary
Miglustat is used to treat Gaucher disease type 1 (a condition in which a certain fatty substance is not broken down normally in the body and instead builds up in some organs and causes liver, spleen, bone, and blood problems). Miglustat is also used in combination with another medication known as cipaglucosidase alfa-atga (Pombilti) to treat late onset Pompe disease (a genetic condition that causes deficiency in lysosomal acid alpha-glucosidase, which can lead to muscle weakness and wasting) in adult patients who weigh 92 pounds (40 kg) or more and who have not been improving on their enzyme therapy. Miglustat is in a class of medications called enzyme inhibitors. It works by preventing the body from producing the fatty substance so that less of it will build up in the body and cause symptoms.
Related Packages: 42799-0709-15Last Updated: 04/14/2024
MedLinePlus Full Drug Details: Miglustat
Product Information
| NDC | 42799-0709 |
|---|---|
| Product ID | 42799-709_0841c5c7-f6f9-4e2d-bca6-c5a9f76b5d81 |
| Associated GPIs | |
| GCN Sequence Number | 051970 |
| GCN Sequence Number Description | miglustat CAPSULE 100 MG ORAL |
| HIC3 | Z1G |
| HIC3 Description | GLUCOSYLCERAMIDE SYNTHASE (GCS) INHIBITOR |
| GCN | 19453 |
| HICL Sequence Number | 025098 |
| HICL Sequence Number Description | MIGLUSTAT |
| Brand/Generic | Generic |
| Proprietary Name | Yargesa |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Miglustat |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CAPSULE |
| Route | ORAL |
| Active Ingredient Strength | 100 |
| Active Ingredient Units | mg/1 |
| Substance Name | MIGLUSTAT |
| Labeler Name | Edenbridge Pharmaceuticals LLC. |
| Pharmaceutical Class | Glucosylceramide Synthase Inhibitor [EPC], Glucosylceramide Synthase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209821 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 42799-0709-15 (42799070915)
| NDC Package Code | 42799-709-15 |
|---|---|
| Billing NDC | 42799070915 |
| Package | 1 BLISTER PACK in 1 CARTON (42799-709-15) / 15 CAPSULE in 1 BLISTER PACK |
| Marketing Start Date | 2023-10-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |