BYLVAY
- Product NDC
- 74528-020
- 11-digit product format
- 745280020
- Labeler code
- 74528
- Product ID
- 74528-020_3a4fbe0a-d2a7-419f-a1d5-966cda1d7580
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- odevixibat
- Dosage form
- CAPSULE, COATED PELLETS
- Route
- ORAL
- Labeler
- Albireo Pharma, Inc.
- Application
- NDA215498
- Marketing category
- NDA
- Marketing start
- 2021-07-20
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BYLVAY
- Listing expiration
- 2027-12-31
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 |
|---|
| 74528-020-01 | BYLVAY | 1 in 1 CARTON | CAPSULE, COATED PELLETS | 1 | | 9 |
| 74528-020-01 | BYLVAY | 30 in 1 BOTTLE | CAPSULE, COATED PELLETS | 30 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 74528-020 | BYLVAY (ODEVIXIBAT) CAPSULE, COATED PELLETS [ALBIREO PHARMA, INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250328_151f1d3e-2bf4-47ce-b1be-a892de3258fa.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 |
|---|
| 74528-020-01 | 74528002001 | 1 BOTTLE in 1 CARTON (74528-020-01) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE | 1 bottle | 2021-07-20 | 2026-09-30 | No | No | Current |