Miglustat
- Product NDC
- 10148-201
- 11-digit product format
- 101480201
- Labeler code
- 10148
- Product ID
- 10148-201_fa2fce30-3172-6e10-e053-6294a90a1b5f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- miglustat
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- CoTherix, Inc.
- Application
- NDA021348
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2018-04-25
- Substance
- MIGLUSTAT
- Active strength
- 100 mg/1
- Pharmacologic classes
- 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 |
|---|
| 10148-201-15 | Miglustat | 15 in 1 BLISTER PACK | CAPSULE | 15 | | 16 |
| 10148-201-90 | Miglustat | 6 in 1 CARTON | CAPSULE | 6 | | 16 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10148-201 | MIGLUSTAT CAPSULE [COTHERIX, INC.] | 16 | Current NDC, Legacy NDC, 2 package rows | 20230426_76eb7ac8-e0ee-4409-a4e7-e326c6725836.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 10148-201-15 | 10148020115 | 15 in 1 BLISTER PACK | | | | | | Historical |
| 10148-201-90 | 10148020190 | 6 BLISTER PACK in 1 CARTON (10148-201-90) / 15 CAPSULE in 1 BLISTER PACK (10148-201-15) | 6 blister pack | 2018-04-25 | 0000-00-00 | No | No | Current |