Zavesca
- Product NDC
- 66215-201
- 11-digit product format
- 662150201
- Labeler code
- 66215
- Product ID
- 66215-201_f9cb16ee-d325-b331-e053-6394a90ab08c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- miglustat
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Actelion Pharmaceuticals US, Inc.
- Application
- NDA021348
- Marketing category
- NDA
- Marketing start
- 2003-07-31
- 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
- Zavesca
- 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, 541070 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66215-201-15 | Zavesca | 15 in 1 BLISTER PACK | CAPSULE | 15 | | 19 |
| 66215-201-90 | Zavesca | 6 in 1 CARTON | CAPSULE | 6 | | 19 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| miglustat | ACTIVE INGREDIENT | ADN3S497AZ | ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] | 7 | |
| miglustat | ACTIVE MOIETY | ADN3S497AZ | ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] | 7 | |
| ferrosoferric oxide | INACTIVE INGREDIENT | XM0M87F357 | ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] | 7 | |
| gelatin | INACTIVE INGREDIENT | 2G86QN327L | ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] | 7 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] | 7 | |
| povidone k30 | INACTIVE INGREDIENT | U725QWY32X | ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] | 7 | |
| shellac | INACTIVE INGREDIENT | 46N107B71O | ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] | 7 | |
| sodium starch glycolate type a potato | INACTIVE INGREDIENT | 5856J3G2A2 | ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] | 7 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] | 7 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66215-201 | ZAVESCA (MIGLUSTAT) CAPSULE [ACTELION PHARMACEUTICALS US, INC.] | 19 | Current NDC, Legacy NDC, 2 package rows | 20230421_817892d1-ee12-4632-85fc-57ccdf16d7b8.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 |
|---|
| 66215-201-15 | 66215020115 | 15 in 1 BLISTER PACK | | | | | | Historical |
| 66215-201-90 | 66215020190 | 6 BLISTER PACK in 1 CARTON (66215-201-90) / 15 CAPSULE in 1 BLISTER PACK (66215-201-15) | 6 blister pack | 2003-07-31 | 0000-00-00 | No | No | Current |