FDA.reportPublic FDA data

ELYXYB - celecoxib

Product NDC
69557-333
11-digit product format
695570333
Labeler code
69557
Product ID
69557-333_ad5c6af3-1790-4a13-b4e5-6e3af543b2a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
LIQUID
Route
ORAL
Labeler
SCILEX PHARMACEUTICALS INC.
Application
NDA212157
Marketing category
NDA
Marketing start
2023-11-27
Substance
CELECOXIB
Active strength
120 mg/4.8mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ELYXYB - celecoxib
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB120 mg/4.8mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui2373454, 2373460

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69557-333-01ELYXYB - celecoxib6 in 1 CARTONLIQUID63
69557-333-01ELYXYB - celecoxib4.8 mL in 1 BOTTLELIQUID4.83
69557-333-02ELYXYB - celecoxib1 in 1 CARTONLIQUID13
69557-333-02ELYXYB - celecoxib4.8 mL in 1 BOTTLELIQUID4.83

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69557-333-01ML - Milliliter69557-333f4cea1b5-6c48-4127-9133-0f230e21bcb812023-12-05
69557-333-02ML - Milliliter69557-33326eec686-6301-4029-95a6-55c3ed2d466612025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69557-333ELYXYB - CELECOXIB (CELECOXIB) LIQUID [SCILEX PHARMACEUTICALS INC.]3Current NDC, 4 package rows20241206_c8a5de07-9f27-4a54-a885-8089f0307bd7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2373454celecoxib 120 MG in 4.8 mL Oral SolutionPSNc8a5de07-9f27-4a54-a885-8089f0307bd73
2373460Elyxyb 120 MG in 4.8 mL Oral SolutionPSNc8a5de07-9f27-4a54-a885-8089f0307bd73
2373460celecoxib 25 MG/ML Oral Solution [Elyxyb]SBDc8a5de07-9f27-4a54-a885-8089f0307bd73
2373454celecoxib 25 MG/ML Oral SolutionSCDc8a5de07-9f27-4a54-a885-8089f0307bd73
2373460Elyxyb 120 MG per 4.8 mL Oral SolutionSYc8a5de07-9f27-4a54-a885-8089f0307bd73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69557-333-01695570333016 BOTTLE in 1 CARTON (69557-333-01) / 4.8 mL in 1 BOTTLE6 bottle2023-11-27NoNoHistorical
69557-333-02695570333021 BOTTLE in 1 CARTON (69557-333-02) / 4.8 mL in 1 BOTTLE1 bottle2023-11-27YesNoHistorical