FDA.reportPublic FDA data

Celecoxib

Product NDC
80425-0040
11-digit product format
804250040
Labeler code
80425
Product ID
80425-0040_2a987f6b-720a-4be9-e063-6294a90a3f52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA204776
Marketing category
ANDA
Marketing start
2018-06-01
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
80425-0040-1Celecoxib30 in 1 BOTTLECAPSULE307
80425-0040-2Celecoxib60 in 1 BOTTLECAPSULE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0040-1EA - Each80425-004017418216-0c7a-4fea-b2f8-8197717daacd12023-03-13
80425-0040-2EA - Each80425-004076e24646-807b-4ec7-a5d7-a730484fd82e12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0040CELECOXIB CAPSULE [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_af9da1f2-717b-32b6-e053-2995a90ae585.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNaf9da1f2-717b-32b6-e053-2995a90ae5857
205323celecoxib 200 MG Oral CapsuleSCDaf9da1f2-717b-32b6-e053-2995a90ae5857

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80425-0040-18042500400130 CAPSULE in 1 BOTTLE (80425-0040-1) 30 capsule2018-06-010000-00-00NoNoCurrent
80425-0040-28042500400260 CAPSULE in 1 BOTTLE (80425-0040-2) 60 capsule2018-06-010000-00-00NoNoCurrent