FDA.reportPublic FDA data

Celecoxib

Product NDC
80425-0037
11-digit product format
804250037
Labeler code
80425
Product ID
80425-0037_2a987a87-35f3-e046-e063-6294a90aa7c9
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
80425-0037-1Celecoxib30 in 1 BOTTLECAPSULE307
80425-0037-2Celecoxib60 in 1 BOTTLECAPSULE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0037-1EA - Each80425-003779205788-0d0b-4bcc-8dfb-4dff7a691b1012023-03-13
80425-0037-2EA - Each80425-0037bcaef74c-8dd9-46fc-bb58-5581efae9acd12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0037CELECOXIB CAPSULE [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_af73fea0-5cd1-0fa2-e053-2a95a90af8fc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNaf73fea0-5cd1-0fa2-e053-2a95a90af8fc7
205323celecoxib 200 MG Oral CapsuleSCDaf73fea0-5cd1-0fa2-e053-2a95a90af8fc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0037-18042500370130 CAPSULE in 1 BOTTLE (80425-0037-1) 30 capsule2016-03-160000-00-00NoNoCurrent
80425-0037-28042500370260 CAPSULE in 1 BOTTLE (80425-0037-2) 60 capsule2016-03-160000-00-00NoNoCurrent