FDA.reportPublic FDA data

NDC 63629-8247-04 - Vascepa

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
63629-8247
Requested NDC
63629-8247-04
Package NDCs from labels
63629-8247-1, 63629-8247-2, 63629-8247-3, 63629-8247-4, 63629-8247-04
Manufacturer
Bryant Ranch Prepack
Effective date
2026-04-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Vascepa - Bryant Ranch PrepackBryant Ranch Prepack2026-04-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8247-1Vascepa30 in 1 BOTTLECAPSULE307
63629-8247-2Vascepa60 in 1 BOTTLECAPSULE607
63629-8247-3Vascepa120 in 1 BOTTLECAPSULE1207
63629-8247-4Vascepa90 in 1 BOTTLECAPSULE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8247VASCEPA (ICOSAPENT ETHYL) CAPSULE [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 4 package rows20240511_d245ddab-d81b-44bd-90d7-0e4d446d9bf5.zip

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 1 of 26 · 510 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
SILICONE SCARDIMETHICONEHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a7727d1-09d1-3cb3-e063-6294a90a1bc52026-09-01WarningsExact identifier
unii: R0ZB2556P8
Skin Smoothing CareCENTELLA ASIATICA TRITERPENOIDSHaikou Flash Purchase Star Cross-Border Trade Co., Ltd.5a77f521-2948-6c88-e063-6394a90ad18f2026-09-01WarningsExact identifier
unii: R0ZB2556P8
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepack0ee78f22-bed2-48f8-9be8-b8f6ceeeaeaf2026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 1304979
unii: 6GC8A4PAYH
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepack07631e74-48e5-46ec-b8db-4b1bcf62d2832026-08-25Warnings, Adverse reactionsExact identifier
rxcui: 1304979
unii: 6GC8A4PAYH
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepack582638e5-9881-409d-a455-041b5ba6892a2026-08-25Warnings, Adverse reactionsExact identifier
rxcui: 1304979
unii: 6GC8A4PAYH
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
IcosapentICOSAPENT ETHYLBryant Ranch Prepackcc28828d-beab-45cc-a3b6-151c5fee39242026-08-10Warnings, Adverse reactionsExact identifier
rxcui: 1304979
unii: 6GC8A4PAYH
Icosapent EthylICOSAPENT ETHYLBryant Ranch Prepackf9c1a6a6-cda4-49ea-97e9-0d3cf5ab5d4c2026-08-10Warnings, Adverse reactionsExact identifier
rxcui: 1304979
unii: 6GC8A4PAYH
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Icosapent EthylICOSAPENT ETHYLNorthstar Rx LLC45f8bb41-bdb1-4afc-83ec-9dc69720ee9c2026-07-29Warnings, Adverse reactionsExact identifier
rxcui: 1304979
unii: 6GC8A4PAYH

Reported adverse events (FAERS/openFDA)#

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