FDA.reportPublic FDA data

Bylvay

Product NDC
15054-3303
11-digit product format
150543303
Labeler code
15054
Product ID
15054-3303_8caf9de8-b831-4bbf-91c1-12a269bee890
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
odevixibat
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Ipsen Biopharmaceuticals, Inc.
Application
NDA215498
Marketing category
NDA
Marketing start
2024-01-10
Substance
ODEVIXIBAT
Active strength
600 ug/1
Pharmacologic classes
Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bylvay
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ODEVIXIBAT600 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2W150K0UUC
Rxcui2563983, 2563989, 2563991, 2563993, 2563997, 2564001, 2564003, 2564005

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0f548ad1-0750-4bad-bb76-8e859974eef9Product name120220126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15054-3303-1Bylvay30 in 1 BOTTLECAPSULE, COATED PELLETS304
15054-3303-1Bylvay1 in 1 CARTONCAPSULE, COATED PELLETS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15054-3303-1EA - Each15054-33034ae320e3-41da-4d29-a9ca-60251dfca30412025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15054-3303BYLVAY (ODEVIXIBAT) CAPSULE, COATED PELLETS BYLVAY (ODEVIXIBAT) CAPSULE [IPSEN BIOPHARMACEUTICALS, INC.]3Current NDC, 2 package rows20250328_0935cd31-3251-4a0a-ac23-25ca4be12be9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2564005Bylvay 1200 MCG Oral CapsulePSN0935cd31-3251-4a0a-ac23-25ca4be12be94
2563989Bylvay 200 MCG Oral PelletPSN0935cd31-3251-4a0a-ac23-25ca4be12be94
2564001Bylvay 400 MCG Oral CapsulePSN0935cd31-3251-4a0a-ac23-25ca4be12be94
2563993Bylvay 600 MCG Oral PelletPSN0935cd31-3251-4a0a-ac23-25ca4be12be94
2564003odevixibat 1200 MCG Oral CapsulePSN0935cd31-3251-4a0a-ac23-25ca4be12be94
2563983odevixibat 200 MCG Oral PelletPSN0935cd31-3251-4a0a-ac23-25ca4be12be94
2563997odevixibat 400 MCG Oral CapsulePSN0935cd31-3251-4a0a-ac23-25ca4be12be94
2563991odevixibat 600 MCG Oral PelletPSN0935cd31-3251-4a0a-ac23-25ca4be12be94
2563989odevixibat 0.2 MG Oral Pellet [Bylvay]SBD0935cd31-3251-4a0a-ac23-25ca4be12be94
2564001odevixibat 0.4 MG Oral Capsule [Bylvay]SBD0935cd31-3251-4a0a-ac23-25ca4be12be94
2563993odevixibat 0.6 MG Oral Pellet [Bylvay]SBD0935cd31-3251-4a0a-ac23-25ca4be12be94
2564005odevixibat 1.2 MG Oral Capsule [Bylvay]SBD0935cd31-3251-4a0a-ac23-25ca4be12be94
2563983odevixibat 0.2 MG Oral PelletSCD0935cd31-3251-4a0a-ac23-25ca4be12be94
2563997odevixibat 0.4 MG Oral CapsuleSCD0935cd31-3251-4a0a-ac23-25ca4be12be94
2563991odevixibat 0.6 MG Oral PelletSCD0935cd31-3251-4a0a-ac23-25ca4be12be94
2564003odevixibat 1.2 MG Oral CapsuleSCD0935cd31-3251-4a0a-ac23-25ca4be12be94
2563989Bylvay 0.2 MG Oral PelletSY0935cd31-3251-4a0a-ac23-25ca4be12be94
2564001Bylvay 0.4 MG Oral CapsuleSY0935cd31-3251-4a0a-ac23-25ca4be12be94
2563993Bylvay 0.6 MG Oral PelletSY0935cd31-3251-4a0a-ac23-25ca4be12be94
2564005Bylvay 1.2 MG Oral CapsuleSY0935cd31-3251-4a0a-ac23-25ca4be12be94
2564005Bylvay 1200 MCG Oral CapsuleSY0935cd31-3251-4a0a-ac23-25ca4be12be94
2563989Bylvay 200 MCG Oral PelletSY0935cd31-3251-4a0a-ac23-25ca4be12be94
2564001Bylvay 400 MCG Oral CapsuleSY0935cd31-3251-4a0a-ac23-25ca4be12be94
2563993Bylvay 600 MCG Oral PelletSY0935cd31-3251-4a0a-ac23-25ca4be12be94
2564003odevixibat (as odevixibat sesquihydrate) 1200 MCG Oral CapsuleSY0935cd31-3251-4a0a-ac23-25ca4be12be94
2563983odevixibat (as odevixibat sesquihydrate) 200 MCG Oral PelletSY0935cd31-3251-4a0a-ac23-25ca4be12be94
2563997odevixibat (as odevixibat sesquihydrate) 400 MCG Oral CapsuleSY0935cd31-3251-4a0a-ac23-25ca4be12be94
2563991odevixibat (as odevixibat sesquihydrate) 600 MCG Oral PelletSY0935cd31-3251-4a0a-ac23-25ca4be12be94
2564003odevixibat 1200 MCG Oral CapsuleSY0935cd31-3251-4a0a-ac23-25ca4be12be94
2563983odevixibat 200 MCG Oral PelletSY0935cd31-3251-4a0a-ac23-25ca4be12be94
2563997odevixibat 400 MCG Oral CapsuleSY0935cd31-3251-4a0a-ac23-25ca4be12be94
2563991odevixibat 600 MCG Oral PelletSY0935cd31-3251-4a0a-ac23-25ca4be12be94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
15054-3303-1150543303011 BOTTLE in 1 CARTON (15054-3303-1) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE1 bottle2024-01-10NoNoCurrent