bylvay

Generic: odevixibat

Labeler: albireo pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

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

odevixibat 1200 ug/1

Manufacturer
Albireo Pharma, Inc.

Identifiers & Regulatory

Product NDC 74528-120
Product ID 74528-120_3a4fbe0a-d2a7-419f-a1d5-966cda1d7580
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215498
Listing Expiration 2027-12-31
Marketing Start 2021-07-20

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 74528120
Hyphenated Format 74528-120

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
  • 1200 ug/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (74528-120-01) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE
source: ndc

Packages (1)

74528-120-01 1 BOTTLE in 1 CARTON (74528-120-01) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE

Ingredients (1)

odevixibat (1200 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": "3a4fbe0a-d2a7-419f-a1d5-966cda1d7580", "openfda": {"nui": ["N0000193957", "N0000193958"], "unii": ["2W150K0UUC"], "rxcui": ["2563983", "2563989", "2563991", "2563993", "2563997", "2564001", "2564003", "2564005"], "spl_set_id": ["151f1d3e-2bf4-47ce-b1be-a892de3258fa"], "pharm_class_epc": ["Ileal Bile Acid Transporter Inhibitor [EPC]"], "pharm_class_moa": ["Ileal Bile Acid Transporter Inhibitors [MoA]"], "manufacturer_name": ["Albireo Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (74528-120-01)  / 30 CAPSULE, COATED PELLETS in 1 BOTTLE", "package_ndc": "74528-120-01", "marketing_end_date": "20260930", "marketing_start_date": "20210720"}], "brand_name": "BYLVAY", "product_id": "74528-120_3a4fbe0a-d2a7-419f-a1d5-966cda1d7580", "dosage_form": "CAPSULE, COATED PELLETS", "pharm_class": ["Ileal Bile Acid Transporter Inhibitor [EPC]", "Ileal Bile Acid Transporter Inhibitors [MoA]"], "product_ndc": "74528-120", "generic_name": "odevixibat", "labeler_name": "Albireo Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "BYLVAY", "active_ingredients": [{"name": "ODEVIXIBAT", "strength": "1200 ug/1"}], "application_number": "NDA215498", "marketing_category": "NDA", "marketing_start_date": "20210720", "listing_expiration_date": "20271231"}