SKYCLARYS
- Product NDC
- 64406-250
- 11-digit product format
- 644060250
- Labeler code
- 64406
- Product ID
- 64406-250_4fa5df55-d5bf-44d1-856e-937b48e69bb0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omaveloxolone
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Biogen
- Application
- NDA216718
- Marketing category
- NDA
- Marketing start
- 2023-02-28
- Substance
- OMAVELOXOLONE
- Active strength
- 50 mg/1
- Pharmacologic classes
- Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SKYCLARYS
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| OMAVELOXOLONE | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | G69Z98951Q |
| Rxcui | 2631936, 2631942 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 64406-250-90 | SKYCLARYS | 90 in 1 BOTTLE | CAPSULE | 90 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 64406-250 | SKYCLARYS (OMAVELOXOLONE) CAPSULE [BIOGEN] | 7 | Current NDC, 1 package rows | 20250109_2709e870-df3d-f30f-e063-6394a90aeda1.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 |
|---|
| 64406-250-90 | 64406025090 | 90 CAPSULE in 1 BOTTLE (64406-250-90) | 90 capsule | 2024-11-15 | No | No | Current |