FDA.reportPublic FDA data

Celecoxib

Product NDC
80425-0209
11-digit product format
804250209
Labeler code
80425
Product ID
80425-0209_4d64347e-0afc-1844-e063-6394a90a02c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA210071
Marketing category
ANDA
Marketing start
2020-12-21
Substance
CELECOXIB
Active strength
200 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Celecoxib
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205323

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
80425-0209-1Celecoxib30 in 1 BOTTLECAPSULE307
80425-0209-2Celecoxib60 in 1 BOTTLECAPSULE607
80425-0209-3Celecoxib90 in 1 BOTTLECAPSULE907
80425-0209-4Celecoxib180 in 1 BOTTLECAPSULE1807
80425-0209-5Celecoxib6 in 1 BOTTLECAPSULE67

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0209CELECOXIB CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]6Current NDC, Legacy NDC, 5 package rows20250101_eca923da-59fa-da2e-e053-2a95a90a6a51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNeca923da-59fa-da2e-e053-2a95a90a6a517
205323celecoxib 200 MG Oral CapsuleSCDeca923da-59fa-da2e-e053-2a95a90a6a517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0209-18042502090130 CAPSULE in 1 BOTTLE (80425-0209-1) 30 capsule2024-11-04NoNoCurrent
80425-0209-28042502090260 CAPSULE in 1 BOTTLE (80425-0209-2) 60 capsule2024-11-04NoNoCurrent
80425-0209-38042502090390 CAPSULE in 1 BOTTLE (80425-0209-3) 90 capsule2024-11-04NoNoCurrent
80425-0209-480425020904180 CAPSULE in 1 BOTTLE (80425-0209-4) 180 capsule2024-11-04NoNoCurrent
80425-0209-5804250209056 CAPSULE in 1 BOTTLE (80425-0209-5) 6 capsule2026-03-19NoNoCurrent