FDA.reportPublic FDA data

ELYXYB - celecoxib

Product NDC
59385-055
11-digit product format
593850055
Labeler code
59385
Product ID
59385-055_942cdd49-03ae-42ee-a866-a2ab78873d38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
LIQUID
Route
ORAL
Labeler
BioDelivery Sciences International Inc
Application
NDA212157
Marketing category
NDA
Marketing start
2022-01-01
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
120 mg/4.8mL
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
cc117a7e-1ef6-4866-90a7-ce0d190eef9aProduct name120200925
827beb42-45f2-95b8-6aa3-f35174375422Product name920160429

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 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

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 RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2373454celecoxib 120 MG in 4.8 mL Oral SolutionPSNa0bfcba9-0af6-4b45-80e3-c4c94065b7771
2373460Elyxyb 120 MG in 4.8 mL Oral SolutionPSNa0bfcba9-0af6-4b45-80e3-c4c94065b7771
2373460celecoxib 25 MG/ML Oral Solution [Elyxyb]SBDa0bfcba9-0af6-4b45-80e3-c4c94065b7771
2373454celecoxib 25 MG/ML Oral SolutionSCDa0bfcba9-0af6-4b45-80e3-c4c94065b7771
2373460Elyxyb 120 MG per 4.8 mL Oral SolutionSYa0bfcba9-0af6-4b45-80e3-c4c94065b7771

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59385-055-01593850055014.8 mL in 1 BOTTLE4.8 mlHistorical
59385-055-02593850055024.8 mL in 1 BOTTLE4.8 mlHistorical
59385-055-06593850055066 BOTTLE in 1 CARTON (59385-055-06) > 4.8 mL in 1 BOTTLE (59385-055-01) 6 bottle2022-01-010000-00-00NoNoCurrent
59385-055-22593850055221 BOTTLE in 1 CARTON (59385-055-22) > 4.8 mL in 1 BOTTLE (59385-055-02) 1 bottle2022-01-010000-00-00YesNoCurrent