Miglustat
- Product NDC
- 68475-204
- 11-digit product format
- 684750204
- Labeler code
- 68475
- Product ID
- 68475-204_94491d95-3cdd-45cd-b94c-a0d4982618cc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Miglustat
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Navinta LLC
- Application
- ANDA219111
- Marketing category
- ANDA
- Marketing start
- 2025-05-07
- 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 |
|---|
| 68475-204-01 | Miglustat | 15 in 1 BLISTER PACK | CAPSULE | 15 | | 3 |
| 68475-204-02 | Miglustat | 6 in 1 CARTON | CAPSULE | 6 | | 3 |
| 68475-204-03 | Miglustat | 21 in 1 BLISTER PACK | CAPSULE | 21 | | 3 |
| 68475-204-04 | Miglustat | 4 in 1 CARTON | CAPSULE | 4 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68475-204-01 | 68475020401 | 15 in 1 BLISTER PACK | | | | | Historical |
| 68475-204-02 | 68475020402 | 6 BLISTER PACK in 1 CARTON (68475-204-02) / 15 CAPSULE in 1 BLISTER PACK (68475-204-01) | 6 blister pack | 2025-05-07 | No | No | Historical |
| 68475-204-03 | 68475020403 | 21 in 1 BLISTER PACK | | | | | Historical |
| 68475-204-04 | 68475020404 | 4 BLISTER PACK in 1 CARTON (68475-204-04) / 21 CAPSULE in 1 BLISTER PACK (68475-204-03) | 4 blister pack | 2025-12-23 | No | No | Historical |