FDA.reportPublic FDA data

BYLVAY

Product NDC
74528-120
11-digit product format
745280120
Labeler code
74528
Product ID
74528-120_3a4fbe0a-d2a7-419f-a1d5-966cda1d7580
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
odevixibat
Dosage form
CAPSULE, COATED PELLETS
Route
ORAL
Labeler
Albireo Pharma, Inc.
Application
NDA215498
Marketing category
NDA
Marketing start
2021-07-20
Substance
ODEVIXIBAT
Active strength
1200 ug/1
Pharmacologic classes
Ileal Bile Acid Transporter Inhibitor [EPC], Ileal Bile Acid Transporter Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BYLVAY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ODEVIXIBAT1200 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
74528-120-01BYLVAY30 in 1 BOTTLECAPSULE, COATED PELLETS309
74528-120-01BYLVAY1 in 1 CARTONCAPSULE, COATED PELLETS19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
74528-120-01EA - Each74528-120ae1dcf3b-aa58-4cdb-a7a3-333bf2605ae912021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74528-120BYLVAY (ODEVIXIBAT) CAPSULE, COATED PELLETS [ALBIREO PHARMA, INC.]8Current NDC, Legacy NDC, 2 package rows20250328_151f1d3e-2bf4-47ce-b1be-a892de3258fa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2564005Bylvay 1200 MCG Oral CapsulePSN151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563989Bylvay 200 MCG Oral PelletPSN151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2564001Bylvay 400 MCG Oral CapsulePSN151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563993Bylvay 600 MCG Oral PelletPSN151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2564003odevixibat 1200 MCG Oral CapsulePSN151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563983odevixibat 200 MCG Oral PelletPSN151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563997odevixibat 400 MCG Oral CapsulePSN151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563991odevixibat 600 MCG Oral PelletPSN151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563989odevixibat 0.2 MG Oral Pellet [Bylvay]SBD151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2564001odevixibat 0.4 MG Oral Capsule [Bylvay]SBD151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563993odevixibat 0.6 MG Oral Pellet [Bylvay]SBD151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2564005odevixibat 1.2 MG Oral Capsule [Bylvay]SBD151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563983odevixibat 0.2 MG Oral PelletSCD151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563997odevixibat 0.4 MG Oral CapsuleSCD151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563991odevixibat 0.6 MG Oral PelletSCD151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2564003odevixibat 1.2 MG Oral CapsuleSCD151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563989Bylvay 0.2 MG Oral PelletSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2564001Bylvay 0.4 MG Oral CapsuleSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563993Bylvay 0.6 MG Oral PelletSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2564005Bylvay 1.2 MG Oral CapsuleSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2564005Bylvay 1200 MCG Oral CapsuleSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563989Bylvay 200 MCG Oral PelletSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2564001Bylvay 400 MCG Oral CapsuleSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563993Bylvay 600 MCG Oral PelletSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2564003odevixibat (as odevixibat sesquihydrate) 1200 MCG Oral CapsuleSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563983odevixibat (as odevixibat sesquihydrate) 200 MCG Oral PelletSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563997odevixibat (as odevixibat sesquihydrate) 400 MCG Oral CapsuleSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563991odevixibat (as odevixibat sesquihydrate) 600 MCG Oral PelletSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2564003odevixibat 1200 MCG Oral CapsuleSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563983odevixibat 200 MCG Oral PelletSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563997odevixibat 400 MCG Oral CapsuleSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9
2563991odevixibat 600 MCG Oral PelletSY151f1d3e-2bf4-47ce-b1be-a892de3258fa9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
74528-120-01745280120011 BOTTLE in 1 CARTON (74528-120-01) / 30 CAPSULE, COATED PELLETS in 1 BOTTLE1 bottle2021-07-202026-09-30NoNoCurrent