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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N211759-001VYSCOXACELECOXIB10MG/MLSUSPENSION / ORALRLD, RS2025-07-29

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N211759-001126784052045-09-17Drug product2026-08-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N211759-001VYSCOXA10MG/MLSUSPENSION / ORALRLD, RS2025-07-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N211759-001VYSCOXA10MG/MLSUSPENSION / ORALRLD, RS2025-07-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N211759-001VYSCOXA10MG/MLSUSPENSION / ORALRLD, RS2025-07-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N211759-001VYSCOXA10MG/MLSUSPENSION / ORALRLD, RS2025-07-296a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N211759-001VYSCOXA10MG/MLSUSPENSION / ORALRLD, RS2025-07-29a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N211759-001126784052045-09-17Drug product2026-08-12caaa826d4ba7…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
JCX84Q7J1LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2721529Internal RxNorm lookup
2721535Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5094d47e-f791-4190-9397-b7500143a74dAvailable on FDA.report

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VYSCOXACELECOXIBCarwin Pharmaceutical Associates, LLC5094d47e-f791-4190-9397-b7500143a74d2025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 211759
application number: NDA211759
ndc (product): 15370-501

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 ml2025-07-31NoNoCurrent