Yargesa
- Product NDC
- 42799-709
- 11-digit product format
- 427990709
- Labeler code
- 42799
- Product ID
- 42799-709_462f6c9d-b8f1-3a76-e063-6294a90a2b50
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Miglustat
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Edenbridge Pharmaceuticals LLC.
- Application
- ANDA209821
- Marketing category
- ANDA
- Marketing start
- 2020-08-06
- Substance
- MIGLUSTAT
- Active strength
- 100 mg/1
- Pharmacologic classes
- Enzyme Stabilizer [EPC], Enzyme Stabilizers [MoA], Glucosylceramide Synthase Inhibitor [EPC], Glucosylceramide Synthase 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
- Yargesa
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIGLUSTAT | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ADN3S497AZ |
| Rxcui | 401938, 2642350 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42799-709-01 | Yargesa | 6 in 1 CARTON | CAPSULE | 6 | | 5 |
| 42799-709-01 | Yargesa | 15 in 1 BLISTER PACK | CAPSULE | 15 | | 5 |
| 42799-709-15 | Yargesa | 1 in 1 CARTON | CAPSULE | 1 | | 5 |
| 42799-709-15 | Yargesa | 15 in 1 BLISTER PACK | CAPSULE | 15 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42799-709 | YARGESA (MIGLUSTAT) CAPSULE [EDENBRIDGE PHARMACEUTICALS LLC.] | 3 | Current NDC, 4 package rows | 20250418_2b371dfe-e2b0-47fe-b677-a7bde7149f87.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 42799-709-01 | 42799070901 | 6 in 1 CARTON | | | | | Historical |
| 42799-709-15 | 42799070915 | 1 BLISTER PACK in 1 CARTON (42799-709-15) / 15 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2023-10-31 | No | No | Current |