Prescription drug · NDA
Bylvay (Odevixibat) NDC 15054-3301
Odevixibat 200 ug/1 · Capsule, Coated pellets · Oral · Ipsen Biopharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 15054-3301-1 | 1505433010115054330101 | 1 BOTTLE in 1 CARTON (15054-3301-1) / 30 CAPSULE, COATED PELLETS in 1 BOTTLEMarketed from Jan 10, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Bylvay
- Generic name (nonproprietary)
- odevixibat
- Active ingredients
- Odevixibat — 200 ug/1
- Dosage form
- Capsule, Coated pellets
- Route
- Oral
- Labeler
- Ipsen Biopharmaceuticals, Inc.NDC labeler code 15054
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215498
- Marketing start
- Listing expires
- Other FDA classes
- Ileal Bile Acid Transporter Inhibitors (Mechanism)
- Identifiers
- Product ID 15054-3301_8caf9de8-b831-4bbf-91c1-12a269bee890SPL ID 8caf9de8-b831-4bbf-91c1-12a269bee890SPL set ID 0935cd31-3251-4a0a-ac23-25ca4be12be9RxCUI 2563983, 2563989, 2563991, 2563993, 2563997, 2564001, 2564003, 2564005UNII 2W150K0UUC
- Pharmacologic class
- Ileal Bile Acid Transporter Inhibitor
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N415054330101followed by a unit qualifier and the quantityPackage 15054-3301-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
BYLVAY is an ileal bile acid transporter (IBAT) inhibitor indicated for: Progressive Familial Intrahepatic Cholestasis (PFIC) the treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC). ( 1.1 ) Limitation of Use : BYLVAY is not recommended in a subgroup of PFIC type 2 patients with specific ABCB11 variants resulting in non-functional or complete absence of the bile salt export pump protein. ( 12.5 , 14.1 ) Alagille Syndrome (ALGS) the treatment of cholestatic pruritus in patients 12 months of age and older with Alagille syndrome (ALGS). ( 1.2 ) 1.1 Progressive Familial Intrahepatic Cholestasis (PFIC) BYLVAY is indicated for the t…
Excerpt only. Read the full label for complete information.
About NDC 15054-3301
- What is NDC 15054-3301?
- 15054-3301 is the product NDC for Bylvay (odevixibat), Odevixibat 200 ug/1 capsule, coated pellets, listed with the FDA by Ipsen Biopharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Bylvay (Odevixibat).
- What is the active ingredient?
- Odevixibat.
- Who is the labeler?
- Ipsen Biopharmaceuticals, Inc., NDC labeler code 15054. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Bylvay?
- 3 other product NDCs are listed under this name. See all Bylvay NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Bylvay products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Bylvayodevixibat | Odevixibat 400 ug/1 | CapsuleOral | Ipsen Biopharmaceuticals, Inc. | 15054-3302 | 15054-3302-01 |
| Bylvayodevixibat | Odevixibat 600 ug/1 | Capsule, Coated pelletsOral | Ipsen Biopharmaceuticals, Inc. | 15054-3303 | 15054-3303-01 |
| Bylvayodevixibat | Odevixibat 1200 ug/1 | CapsuleOral | Ipsen Biopharmaceuticals, Inc. | 15054-3304 | 15054-3304-01 |
Other NDCs under NDA 215498
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Bylvayodevixibat | Odevixibat 400 ug/1 | CapsuleOral | Ipsen Biopharmaceuticals, Inc. | 15054-3302 |
| Bylvayodevixibat | Odevixibat 600 ug/1 | Capsule, Coated pelletsOral | Ipsen Biopharmaceuticals, Inc. | 15054-3303 |
| Bylvayodevixibat | Odevixibat 1200 ug/1 | CapsuleOral | Ipsen Biopharmaceuticals, Inc. | 15054-3304 |