bylvay

Generic: odevixibat

Labeler: ipsen biopharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name bylvay
Generic Name odevixibat
Labeler ipsen biopharmaceuticals, inc.
Dosage Form CAPSULE, COATED PELLETS
Routes
ORAL
Active Ingredients

odevixibat 200 ug/1

Manufacturer
Ipsen Biopharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 15054-3301
Product ID 15054-3301_8caf9de8-b831-4bbf-91c1-12a269bee890
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215498
Listing Expiration 2026-12-31
Marketing Start 2024-01-10

Pharmacologic Class

Established (EPC)
ileal bile acid transporter inhibitor [epc]
Mechanism of Action
ileal bile acid transporter inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 150543301
Hyphenated Format 15054-3301

Supplemental Identifiers

RxCUI
2563983 2563989 2563991 2563993 2563997 2564001 2564003 2564005
UNII
2W150K0UUC
NUI
N0000193957 N0000193958

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name bylvay (source: ndc)
Generic Name odevixibat (source: ndc)
Application Number NDA215498 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 ug/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (15054-3301-1) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE
source: ndc

Packages (1)

15054-3301-1 1 BOTTLE in 1 CARTON (15054-3301-1) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE

Ingredients (1)

odevixibat (200 ug/1)

Linked Drug Pages (1)

Bylvay ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8caf9de8-b831-4bbf-91c1-12a269bee890", "openfda": {"nui": ["N0000193957", "N0000193958"], "unii": ["2W150K0UUC"], "rxcui": ["2563983", "2563989", "2563991", "2563993", "2563997", "2564001", "2564003", "2564005"], "spl_set_id": ["0935cd31-3251-4a0a-ac23-25ca4be12be9"], "pharm_class_epc": ["Ileal Bile Acid Transporter Inhibitor [EPC]"], "pharm_class_moa": ["Ileal Bile Acid Transporter Inhibitors [MoA]"], "manufacturer_name": ["Ipsen Biopharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (15054-3301-1)  / 30 CAPSULE, COATED PELLETS in 1 BOTTLE", "package_ndc": "15054-3301-1", "marketing_start_date": "20240110"}], "brand_name": "Bylvay", "product_id": "15054-3301_8caf9de8-b831-4bbf-91c1-12a269bee890", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Ileal Bile Acid Transporter Inhibitor [EPC]", "Ileal Bile Acid Transporter Inhibitors [MoA]"], "product_ndc": "15054-3301", "generic_name": "odevixibat", "labeler_name": "Ipsen Biopharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bylvay", "active_ingredients": [{"name": "ODEVIXIBAT", "strength": "200 ug/1"}], "application_number": "NDA215498", "marketing_category": "NDA", "marketing_start_date": "20240110", "listing_expiration_date": "20261231"}