FDA.reportPublic FDA data

Celecoxib

Product NDC
80425-0096
11-digit product format
804250096
Labeler code
80425
Product ID
80425-0096_2a998d83-7baa-3f5e-e063-6294a90acd3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA204590
Marketing category
ANDA
Marketing start
2016-03-16
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
80425-0096-1Celecoxib30 in 1 BOTTLECAPSULE309
80425-0096-2Celecoxib60 in 1 BOTTLECAPSULE609
80425-0096-3Celecoxib90 in 1 BOTTLECAPSULE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0096-1EA - Each80425-0096b2178a8e-0b27-40b9-bb3a-0d3428af866412023-03-13
80425-0096-2EA - Each80425-0096ef334fbf-58aa-4935-9fbb-77be75e8dbdc12023-03-13
80425-0096-3EA - Each80425-00962744e407-261b-41dd-83bb-0f9ddae465d312023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0096CELECOXIB CAPSULE [ADVANCED RX OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 3 package rows20250101_b3545cfb-97c3-b896-e053-2a95a90a15a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNb3545cfb-97c3-b896-e053-2a95a90a15a09
205323celecoxib 200 MG Oral CapsuleSCDb3545cfb-97c3-b896-e053-2a95a90a15a09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0096-18042500960130 CAPSULE in 1 BOTTLE (80425-0096-1) 30 capsule2016-03-160000-00-00NoNoCurrent
80425-0096-28042500960260 CAPSULE in 1 BOTTLE (80425-0096-2) 60 capsule2016-03-160000-00-00NoNoCurrent
80425-0096-38042500960390 CAPSULE in 1 BOTTLE (80425-0096-3) 90 capsule2016-03-160000-00-00NoNoCurrent