FDA.reportPublic FDA data

NDC 59385-055-01 - ELYXYB - celecoxib

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
59385-055
Requested NDC
59385-055-01
Package NDCs from labels
59385-055-01, 59385-055-06, 59385-055-02, 59385-055-22
Manufacturer
BioDelivery Sciences International Inc
Effective date
2021-10-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ELYXYB - celecoxib - BioDelivery Sciences International IncBioDelivery Sciences International Inc2021-10-01HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59385-055-062025-01-30C16284748780-12cef2736-9443-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ELYXYB safely and effectively. See full prescribing information for ELYXYB. ELYXYB (celecoxib) oral solution Initial U.S. Approval: 1998
59385-055-222025-01-30C16284748780-12cef2736-9443-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ELYXYB safely and effectively. See full prescribing information for ELYXYB. ELYXYB (celecoxib) oral solution Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59385-055-01ELYXYB - celecoxib4.8 mL in 1 BOTTLELIQUID4.81
59385-055-02ELYXYB - celecoxib4.8 mL in 1 BOTTLELIQUID4.81
59385-055-06ELYXYB - celecoxib6 in 1 CARTONLIQUID61
59385-055-22ELYXYB - celecoxib1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59385-055ELYXYB - CELECOXIB (CELECOXIB) LIQUID [BIODELIVERY SCIENCES INTERNATIONAL INC]1Legacy NDC, 4 package rows20220101_a0bfcba9-0af6-4b45-80e3-c4c94065b777.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59385-055-01ML - Milliliter59385-05595ea0cda-0b6e-4c36-82c5-bb49474c1aec12021-12-08
59385-055-06ML - Milliliter59385-0556d45fad7-3520-4faf-a2e3-3476d373308912021-12-08

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 9 of 167 · 3,321 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gingerbread Scented Hand SanitizerETHYL ALCOHOLPacific World Corporation5014eea8-6ee3-5ed2-e063-6294a90adac42026-08-05WarningsExact identifier
unii: 3K9958V90M
Frosted Cherry Scented Hand SanitizerETHYL ALCOHOLPacific World Corporation4ffcf42b-c650-7c76-e063-6394a90a059c2026-08-05WarningsExact identifier
unii: 3K9958V90M
BBlove Hand Sanitizer JAPANESE CHERRY BLOSSOMALCOHOLShenzhen Lantern Scicence Co.,Ltd.5833c261-021a-2db2-e063-6394a90a22b02026-08-04WarningsExact identifier
unii: 3K9958V90M
BBlove Hand Sanitizer Soft PetalsALCOHOLShenzhen Lantern Scicence Co.,Ltd.583438a6-c06c-87f5-e063-6394a90adec12026-08-04WarningsExact identifier
unii: 3K9958V90M
BBlove Hand Sanitizer Hibiscus and AloeALCOHOLShenzhen Lantern Scicence Co.,Ltd.5834801e-20e5-bffb-e063-6394a90a03592026-08-04WarningsExact identifier
unii: 3K9958V90M
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact identifier
unii: PDC6A3C0OX
Germs Be Gone Antiseptic Hand Sanitizer Clean and FreshALCOHOLRejoice Industries Canada Inc.1c11a785-d60c-4159-8e63-5ddcf88c23b02026-08-04WarningsExact identifier
unii: 3K9958V90M
MG DermaSpray 70ETHYL ALCOHOLMorgan Gallacher Inc. DBA Custom Chemical Formulators Inc.153ed8ff-5632-4f21-84de-2b87ac2bef312026-08-04WarningsExact identifier
unii: 3K9958V90M
ALCOHOL WIPEALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO.,LTD57086be5-b7a5-b61e-e063-6394a90abe792026-08-03WarningsExact identifier
unii: 3K9958V90M
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.b06ced10-81c6-4f48-a205-1e0db228cb8b2026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
BBlove Hand Sanitizer Passion Fruit SplashALCOHOLShenzhen Lantern Scicence Co.,Ltd.583159a9-331a-b53b-e063-6294a90a41a32026-08-03WarningsExact identifier
unii: 3K9958V90M
BBlove Hand Sanitizer Fresh Squeezed SpearmintALCOHOLShenzhen Lantern Scicence Co.,Ltd.581b4b8d-fe65-f297-e063-6394a90a5a432026-08-02WarningsExact identifier
unii: 3K9958V90M
Mistify Hand Sanitizer Cotton Candy and Gummy BearALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5987e492-b3b6-ed57-e063-6394a90a223a2026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Hand Sanitizer Soft Serve And Cherry CrushALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5987ed0c-2560-f787-e063-6394a90af7bd2026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Hand Sanitizer Coconut And Whipped CreamALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5988393d-1554-5588-e063-6394a90a470f2026-08-01WarningsExact identifier
unii: 3K9958V90M
Sherk Hand Sanitizer Green Apple And WatermelonALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd598ec764-bad1-d14b-e063-6394a90a23052026-08-01WarningsExact identifier
unii: 3K9958V90M
Sherk Hand Sanitizer Blue Blueberry And Waffle SyrupALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd598f14fc-c34c-0b4e-e063-6394a90acf0c2026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Lavender Hand SanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a0a6abf-fbab-3db5-e063-6294a90a6a302026-08-01WarningsExact identifier
unii: 3K9958V90M
Mistify Watermelon Hand SanitizerALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a0ac249-7b91-a83f-e063-6294a90a93742026-08-01WarningsExact identifier
unii: 3K9958V90M
MISTIFY VANILLA SUGAR COOKIES HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5a0b1e6c-850c-05e0-e063-6294a90afa462026-08-01WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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