Bylvay
- Product NDC
- 15054-3301
- 11-digit product format
- 150543301
- Labeler code
- 15054
- Product ID
- 15054-3301_8caf9de8-b831-4bbf-91c1-12a269bee890
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- odevixibat
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- Ipsen Biopharmaceuticals, Inc.
- Application
- NDA215498
- Marketing category
- NDA
- Marketing start
- 2024-01-10
- Substance
- ODEVIXIBAT
- Active strength
- 200 ug/1
- Pharmacologic classes
- Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter 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
- Bylvay
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ODEVIXIBAT | 200 ug/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2W150K0UUC |
| Rxcui | 2563983, 2563989, 2563991, 2563993, 2563997, 2564001, 2564003, 2564005 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 15054-3301-1 | Bylvay | 1 in 1 CARTON | CAPSULE, COATED PELLETS | 1 | | 4 |
| 15054-3301-1 | Bylvay | 30 in 1 BOTTLE | CAPSULE, COATED PELLETS | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 15054-3301 | BYLVAY (ODEVIXIBAT) CAPSULE, COATED PELLETS BYLVAY (ODEVIXIBAT) CAPSULE [IPSEN BIOPHARMACEUTICALS, INC.] | 3 | Current NDC, 2 package rows | 20250328_0935cd31-3251-4a0a-ac23-25ca4be12be9.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 |
|---|
| 15054-3301-1 | 15054330101 | 1 BOTTLE in 1 CARTON (15054-3301-1) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE | 1 bottle | 2024-01-10 | No | No | Current |