Cerdelga
- Product NDC
- 58468-0220
- 11-digit product format
- 584680220
- Labeler code
- 58468
- Product ID
- 58468-0220_e71b0b39-5a29-4e38-8500-55b6d1f48543
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- eliglustat
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Genzyme Corporation
- Application
- NDA205494
- Marketing category
- NDA
- Marketing start
- 2014-09-03
- Substance
- ELIGLUSTAT
- Active strength
- 84 mg/1
- Pharmacologic classes
- Cytochrome P450 2D6 Inhibitors [MoA], Glucosylceramide Synthase Inhibitor [EPC], Glucosylceramide Synthase Inhibitors [MoA], P-Glycoprotein 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
- Cerdelga
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ELIGLUSTAT | 84 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | DR40J4WA67 |
| Rxcui | 1547225, 1547231 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58468-0220-1 | Cerdelga | 14 in 1 BLISTER PACK | CAPSULE | 14 | | 13 |
| 58468-0220-1 | Cerdelga | 4 in 1 CARTON | CAPSULE | 4 | | 13 |
| 58468-0220-2 | Cerdelga | 14 in 1 BLISTER PACK | CAPSULE | 14 | | 13 |
| 58468-0220-2 | Cerdelga | 1 in 1 CARTON | CAPSULE | 1 | | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 58468-0220 | CERDELGA (ELIGLUSTAT) CAPSULE [GENZYME CORPORATION] | 13 | Current NDC, Legacy NDC, 4 package rows | 20240310_819f828a-b888-4e46-83fc-94d774a28a83.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 |
|---|
| 58468-0220-1 | 58468022001 | 4 BLISTER PACK in 1 CARTON (58468-0220-1) / 14 CAPSULE in 1 BLISTER PACK | 4 blister pack | 2014-09-03 | 0000-00-00 | No | No | Current |
| 58468-0220-2 | 58468022002 | 1 BLISTER PACK in 1 CARTON (58468-0220-2) / 14 CAPSULE in 1 BLISTER PACK | 1 blister pack | 2014-09-03 | 0000-00-00 | No | No | Current |