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 8 of 167 · 3,321 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
B-Pure Moisturizing Hand Sanitizer Raspberry White Tea ScentedALCOHOLFourstar Group USA, Inc.c673389a-7154-440f-a1d4-60fe7bcf54f22026-08-07WarningsExact identifier
unii: 3K9958V90M
CVS Beauty Hydrating Hand Sanitizer SANDALWOOD MUSKETHYL ALCOHOLCVS Pharmacy, Inc.60128fc3-b127-44ee-9e9b-384d322d213a2026-08-07WarningsExact identifier
unii: 3K9958V90M
CVS Beauty Hydrating Hand Sanitizer Sea Salt and LavenderETHYL ALCOHOLCVS Pharmacy, Inc.6c160826-ad98-4390-a07b-c92a2ae5b1812026-08-07WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer ROSEWATER SPRITZALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585cb4fa-6016-1550-e063-6294a90a514d2026-08-06WarningsExact identifier
unii: 3K9958V90M
ALCOHOL WIPEALCOHOL CLOTHJINHUA JINGDI MEDICAL SUPPLIES CO.,LTD585daf42-ec83-d222-e063-6294a90a83702026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer PASSION MANGO SPLASHALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585df6ce-4625-d5d2-e063-6394a90a7fcb2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer LILY SPRINGSALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e0c24-7f5f-4ba7-e063-6294a90a75972026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer WATERMELON POPALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e3ced-fa45-8576-e063-6294a90af50f2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer ALOE BREEZEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e647c-2904-2d3f-e063-6394a90a2b792026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer LAVENDER DREAMALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585e8222-fad5-4409-e063-6394a90a9c602026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer JUICY APPLEALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585eb222-5495-65ed-e063-6394a90a7cfa2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hydrating Hand Sanitizer PEACH GLOWALCOHOL 75%Guangzhou Ailizhuangsi Cosmetics Co., Ltd.585ed56e-362e-7c50-e063-6394a90a19322026-08-06WarningsExact identifier
unii: 3K9958V90M
Uline Hand SanitizerALCOHOLUlinea7aa3bde-d36e-f9d4-e053-2a95a90a6e6a2026-08-06WarningsExact identifier
unii: 3K9958V90M
MagiCare Premium Hand Sanitizing Wipes LavenderALCOHOLMagicare Tech Corp9b66b3bd-1e08-485e-b961-b67a2fcc47512026-08-06WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Hyaluronic Acid Enchanted Rose ScentedALCOHOLFourstar Group USA, Inc.b8216dd0-82e9-411c-b045-d6966a17f18e2026-08-06WarningsExact identifier
unii: 3K9958V90M
B-Pure Moisturizing Hand Sanitizer with Collagen Sugared Iris ScentedALCOHOLFourstar Group USA, Inc.c5b42ae3-475d-444c-8ff0-784f02ec0ee42026-08-06WarningsExact identifier
unii: 3K9958V90M
Smart Care Sweet Pea HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.143082de-5f48-4229-a39e-fd6aa38acf302026-08-06WarningsExact identifier
unii: 3K9958V90M
Smart Care Cherry Blossom HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.ba91112c-5091-4972-84c9-5447eb0b504c2026-08-06WarningsExact identifier
unii: 3K9958V90M
Hand Sanitizer GelETHYL ALCOHOLApollo Health and Beauty Care5245e2a0-f871-ded0-e063-6394a90a86072026-08-05WarningsExact identifier
unii: 3K9958V90M
Vitamin E and AloeETHYL ALCOHOLApollo Health and Beauty Care52460290-a376-24b3-e063-6394a90a63482026-08-05WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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