FDA.reportPublic FDA data

VYSCOXA

Product NDC
15370-501
11-digit product format
153700501
Labeler code
15370
Product ID
15370-501_28480106-933c-452e-acfd-75e1fe7179e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
SUSPENSION
Route
ORAL
Labeler
Carwin Pharmaceutical Associates, LLC
Application
NDA211759
Marketing category
NDA
Marketing start
2025-07-31
Substance
CELECOXIB
Active strength
10 mg/mL
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
VYSCOXA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui2721529, 2721535

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
15370-501-16VYSCOXA473 mL in 1 BOTTLESuspension4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15370-501-16ML - Milliliter15370-501afc3a672-d63b-4d0e-993f-c9fde9d7048e12025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2721529celecoxib 10 MG in 1 mL Oral SuspensionPSN5094d47e-f791-4190-9397-b7500143a74d1
2721535VYSCOXA 10 MG in 1 mL Oral SuspensionPSN5094d47e-f791-4190-9397-b7500143a74d1
2721535celecoxib 10 MG/ML Oral Suspension [Vyscoxa]SBD5094d47e-f791-4190-9397-b7500143a74d1
2721529celecoxib 10 MG/ML Oral SuspensionSCD5094d47e-f791-4190-9397-b7500143a74d1
2721529celecoxib 10 MG per 1 ML Oral SuspensionSY5094d47e-f791-4190-9397-b7500143a74d1
2721535Vyscoxa 10 MG per 1 ML Oral SuspensionSY5094d47e-f791-4190-9397-b7500143a74d1
2721535Vyscoxa 10 MG/ML Oral SuspensionSY5094d47e-f791-4190-9397-b7500143a74d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
15370-501-1615370050116473 mL in 1 BOTTLE (15370-501-16) 473 ml2025-07-31NoNoHistorical