FDA.reportPublic FDA data

CELECOXIB

Product NDC
72189-123
11-digit product format
721890123
Labeler code
72189
Product ID
72189-123_4c5d46ae-1be9-64a4-e063-6294a90ac02b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Direct Rx
Application
ANDA204590
Marketing category
ANDA
Marketing start
2020-08-10
Substance
CELECOXIB
Active strength
100 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
CELECOXIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322

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
72189-123-30CELECOXIB30 in 1 BOTTLECAPSULE307
72189-123-60CELECOXIB60 in 1 BOTTLECAPSULE607
72189-123-71CELECOXIB100 in 1 BOTTLECAPSULE1007
72189-123-72CELECOXIB120 in 1 BOTTLECAPSULE1207
72189-123-90CELECOXIB90 in 1 BOTTLECAPSULE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-123-30EA - Each72189-123a826976b-4665-4dd6-8f78-bebd93cfc79712022-09-12
72189-123-60EA - Each72189-123f0e7e87d-d132-42e9-bcb4-b78d4e8498e012020-09-14
72189-123-72EA - Each72189-1239fb5c694-664b-4bee-a36c-4c297202adc412022-03-09
72189-123-90EA - Each72189-123482822b0-4e3b-4ffd-a42c-0256b0b214b012025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-123CELECOXIB CAPSULE [DIRECT RX]5Current NDC, Legacy NDC, 5 package rows20250119_ac87b4f9-3f66-8cf7-e053-2995a90ade0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNac87b4f9-3f66-8cf7-e053-2995a90ade0f7
205322celecoxib 100 MG Oral CapsuleSCDac87b4f9-3f66-8cf7-e053-2995a90ade0f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-123-307218901233030 CAPSULE in 1 BOTTLE (72189-123-30) 30 capsule2020-08-100000-00-00NoNoCurrent
72189-123-607218901236060 CAPSULE in 1 BOTTLE (72189-123-60) 60 capsule2020-08-100000-00-00NoNoCurrent
72189-123-7172189012371100 CAPSULE in 1 BOTTLE (72189-123-71) 100 capsule2020-08-10NoNoCurrent
72189-123-7272189012372120 CAPSULE in 1 BOTTLE (72189-123-72) 120 capsule2020-08-100000-00-00NoNoCurrent
72189-123-907218901239090 CAPSULE in 1 BOTTLE (72189-123-90) 90 capsule2020-08-10NoNoCurrent