FDA.reportPublic FDA data

NDC 15054-3302-01 - Bylvay

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
15054-3302
Requested NDC
15054-3302-01
Package NDCs from labels
15054-3302-1, 15054-3302-01
Manufacturer
Ipsen Biopharmaceuticals, Inc. | Syngene International Limited. | Almac Pharma Services Limited
Effective date
2025-12-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Bylvay - Ipsen Biopharmaceuticals, Inc. | Syngene International Limited. | Almac Pharma Services LimitedIpsen Biopharmaceuticals, Inc. | Syngene International Limited. | Almac Pharma Services Limited2025-12-29HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15054-3302-1Bylvay30 in 1 BOTTLECAPSULE304
15054-3302-1Bylvay1 in 1 CARTONCAPSULE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15054-3302BYLVAY (ODEVIXIBAT) CAPSULE, COATED PELLETS BYLVAY (ODEVIXIBAT) CAPSULE [IPSEN BIOPHARMACEUTICALS, INC.]3Current NDC, 2 package rows20250328_0935cd31-3251-4a0a-ac23-25ca4be12be9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15054-3302-1EA - Each15054-3302c9593441-5302-4dcc-a60a-acb84e60c65812025-05-14

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 2 · 34 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artificial TearsGLYCERINGeri-Care Pharmaceuticals, Corp7cc437e3-bad9-59be-e053-2991aa0a1da32025-12-19WarningsExact identifier
unii: 3NXW29V3WO
Artificial TearsGLYCERINNuCare Pharmaceuticals,Inc.97a3d8e2-b2c0-3f5d-e053-2a95a90ac49d2025-12-15WarningsExact identifier
unii: 3NXW29V3WO
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Advanced Eye Relief/ Redness Maximum ReliefNAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSEBausch & Lomb Incorporated3c11285a-7e86-4b47-b1ee-e7d59858087d2024-09-25WarningsExact identifier
unii: 3NXW29V3WO
GENTEAL TEARSDEXTRAN 70, GLYCERIN, HYPROMELLOSEA-S Medication Solutionsa2b715e9-332d-4f0b-b8e5-ebc0006815862024-01-21WarningsExact identifier
unii: 3NXW29V3WO
Equate Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Wal-Mart Stores, Inc.91fb8fb5-b871-4535-e053-2995a90a9b162023-12-23WarningsExact identifier
unii: 3NXW29V3WO
Sunmark Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Strategic Sourcing Services LLC043ccc34-44ee-416a-88bc-f247774e90752023-12-23WarningsExact identifier
unii: 3NXW29V3WO
Rite Aid Eye Drops Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Rite Aid Corporationfa1b5b66-9643-e9a7-e053-6394a90ae3cf2023-12-23WarningsExact identifier
unii: 3NXW29V3WO
Meijer Dry Eye ReliefGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Meijer Distribution, Inc.9feaa5e2-6aca-96e8-e053-2a95a90a54bd2023-12-22WarningsExact identifier
unii: 3NXW29V3WO
Walgreens Multi-Symptom Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATEWalgreen Co.a03789ce-66bd-7b12-e053-2995a90af85a2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
Walgreens Lubricant Eye Drops Preservative FreeDEXTRAN 70, HYPROMELLOSEWalgreen Company9b383e41-e116-1c12-e053-2a95a90ab25f2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
TopCare Health Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Topco Associates LLC9c617e34-fc66-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact identifier
unii: 3NXW29V3WO
GenTeal Tears (Moderate)DEXTRAN 70, GLYCERIN, HYPROMELLOSEAlcon Laboratories, Inc.a2992597-3490-6a5c-be45-2b6fa15e15472023-12-15WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.