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 6 of 167 · 3,321 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlcoholALCOHOLLidl US, LLCc7746330-2943-491a-bafc-0c8dd4fa40e22026-08-18Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
AlcoholALCOHOLNice-Pak Products, LLCdc071394-60de-4b13-a962-9a643b01b1062026-08-18Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
HDXETHYL ALCOHOLApollo Health and Beauty Caredf0063b2-2e30-428e-b5cf-24e566c388c22026-08-18WarningsExact identifier
unii: 3K9958V90M
WISH ADVANCED HAND SANITIZER BLACK PLUM VANILLAALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA595f0c9f-645d-a047-e063-6294a90a996a2026-08-18WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER cherry rougeALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593a7fc9-8d56-f9cb-e063-6294a90a3dae2026-08-17WarningsExact identifier
unii: 3K9958V90M
CelecoxibCELECOXIBREMEDYREPACK INC.b3acbfd9-a1c2-4aa6-b5f0-013cfad6cca82026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
Ethyl alcohol 62%ETHYL ALCOHOL 62%UpLift Brands LLC5941ee9e-d109-b2be-e063-6394a90aa3232026-08-17Warnings, Adverse reactionsExact identifier
unii: 3K9958V90M
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: PDC6A3C0OX
WISH HAND SANITIZER Sea Salt Green HerbsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59259ea7-f1bb-9688-e063-6394a90afb3c2026-08-16WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Marshmallow VanillaALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5925e9a7-eb93-c0e3-e063-6294a90ad2652026-08-16WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Lychee Vanilla MilkALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA592625c8-cbc5-f864-e063-6394a90aeb9d2026-08-16WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Banana Cream SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5912d7e8-94a7-e8b9-e063-6394a90a74d62026-08-15WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Caramel Vanilla PopcornALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA591317be-856e-1374-e063-6394a90a7aaf2026-08-15WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Strawberry MuskALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA59143edb-41fe-0a1f-e063-6394a90a81a52026-08-15WarningsExact identifier
unii: 3K9958V90M
FRESH FEELS HAND SANITIZER MIST ICED SUGAR COOKIE SCENTETHYL ALCOHOLAmber Glow Cosmetics Limitedb83a5eef-e2ae-4044-9dce-fd69a5ec5e812026-08-14WarningsExact identifier
unii: 3K9958V90M
WISH HAND SANITIZER Rose WoodsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58fb4491-2918-c486-e063-6394a90a621f2026-08-14WarningsExact identifier
unii: 3K9958V90M
Alcohol Sanitizer Spray.ETHYL ALCOHOLGuangdong Yanze Biotechnology Co., Ltd.58fb9efe-43f0-1b7f-e063-6394a90a01452026-08-14WarningsExact identifier
unii: 3K9958V90M
CelecoxibCELECOXIBREMEDYREPACK INC.e18d2fa4-4982-4e2a-af55-4319d6416efb2026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
BM BM164 DROPSARUM TRYPH, CAUSTICUM, BALSAMUM PERU, HELONIAS DIO, ACID PHOS, GLYCERINUM, EQUISETUMBM Private Limited5902770f-eb01-d099-e063-6394a90ad3eb2026-08-14WarningsExact identifier
unii: PDC6A3C0OX
FRESH FEELS HAND SANITIZER MIST CHILL COCONUT SCENTETHYL ALCOHOLAmber Glow Cosmetics Limited6da508ab-176c-4cca-aa1b-c161d9160cd12026-08-14WarningsExact identifier
unii: 3K9958V90M

Reported adverse events (FAERS/openFDA)#

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