FDA.reportPublic FDA data

Celecoxib

Product NDC
72189-360
11-digit product format
721890360
Labeler code
72189
Product ID
72189-360_2c4c994d-b6d7-0320-e063-6394a90ae3d6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
DirectRx
Application
ANDA205129
Marketing category
ANDA
Marketing start
2022-06-08
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
72189-360-10Celecoxib10 in 1 BOTTLECAPSULE102
72189-360-30Celecoxib30 in 1 BOTTLECAPSULE302
72189-360-42Celecoxib42 in 1 BOTTLECAPSULE422
72189-360-60Celecoxib60 in 1 BOTTLECAPSULE602
72189-360-90Celecoxib90 in 1 BOTTLECAPSULE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-360CELECOXIB CAPSULE [DIRECTRX]2Current NDC, Legacy NDC, 5 package rows20250123_e0f3aacf-df5d-dad7-e053-2995a90ac5eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNe0f3aacf-df5d-dad7-e053-2995a90ac5eb2
205323celecoxib 200 MG Oral CapsuleSCDe0f3aacf-df5d-dad7-e053-2995a90ac5eb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-360-107218903601010 CAPSULE in 1 BOTTLE (72189-360-10) 10 capsule2022-06-080000-00-00NoNoCurrent
72189-360-307218903603030 CAPSULE in 1 BOTTLE (72189-360-30) 30 capsule2022-06-080000-00-00NoNoCurrent
72189-360-427218903604242 CAPSULE in 1 BOTTLE (72189-360-42) 42 capsule2022-06-080000-00-00NoNoCurrent
72189-360-607218903606060 CAPSULE in 1 BOTTLE (72189-360-60) 60 capsule2022-06-080000-00-00NoNoCurrent
72189-360-907218903609090 CAPSULE in 1 BOTTLE (72189-360-90) 90 capsule2022-06-080000-00-00NoNoCurrent