Miglustat
- Product NDC
- 70710-2039
- 11-digit product format
- 707102039
- Labeler code
- 70710
- Product ID
- 70710-2039_3b0d8e2b-b3c4-4a26-a126-420f56734843
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Miglustat
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA219111
- Marketing category
- ANDA
- Marketing start
- 2025-04-01
- 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
- Miglustat
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-2039-4 | Miglustat | 15 in 1 BLISTER PACK | CAPSULE | 15 | | 1 |
| 70710-2039-8 | Miglustat | 6 in 1 CARTON | CAPSULE | 6 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-2039 | MIGLUSTAT CAPSULE [ZYDUS PHARMACEUTICALS USA INC.] | 1 | Current NDC, 2 package rows | 20250402_b54cc8a0-2284-44c3-a8fa-d8aaa87a67c6.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 |
|---|
| 70710-2039-4 | 70710203904 | 15 in 1 BLISTER PACK | | | | | Historical |
| 70710-2039-8 | 70710203908 | 6 BLISTER PACK in 1 CARTON (70710-2039-8) / 15 CAPSULE in 1 BLISTER PACK (70710-2039-4) | 6 blister pack | 2025-04-01 | No | No | Current |