NDC 74528-060

BYLVAY

Odevixibat

BYLVAY is a Oral Capsule, Coated Pellets in the Human Prescription Drug category. It is labeled and distributed by Albireo Pharma, Inc.. The primary component is Odevixibat.

Product ID74528-060_16dd4a78-9875-4c90-9dee-8f4d6af2e710
NDC74528-060
Product TypeHuman Prescription Drug
Proprietary NameBYLVAY
Generic NameOdevixibat
Dosage FormCapsule, Coated Pellets
Route of AdministrationORAL
Marketing Start Date2021-07-20
Marketing CategoryNDA /
Application NumberNDA215498
Labeler NameAlbireo Pharma, Inc.
Substance NameODEVIXIBAT
Active Ingredient Strength600 ug/1
Pharm ClassesIleal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 74528-060-01

1 BOTTLE in 1 CARTON (74528-060-01) > 30 CAPSULE, COATED PELLETS in 1 BOTTLE
Marketing Start Date2021-07-20
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "BYLVAY" or generic name "Odevixibat"

NDCBrand NameGeneric Name
74528-020BYLVAYodevixibat
74528-040BYLVAYodevixibat
74528-060BYLVAYodevixibat
74528-120BYLVAYodevixibat

Trademark Results [BYLVAY]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BYLVAY
BYLVAY
88932949 not registered Live/Pending
Albireo AB
2020-05-26

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