CELECOXIB

Product NDC
60290-016
11-digit product format
602900016
Labeler code
60290
Product ID
60290-016_499a5e50-a378-7aff-e063-6294a90adc85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Umedica Laboratories USA Inc.
Application
ANDA210628
Marketing category
ANDA
Marketing start
2026-02-15
Substance
CELECOXIB
Active strength
50 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
CELECOXIB50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322, 205323, 349514, 686379

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
60290-016-01CELECOXIB100 in 1 BLISTER PACKCAPSULE10012
60290-016-02CELECOXIB60 in 1 BOTTLECAPSULE6012
60290-016-03CELECOXIB500 in 1 BOTTLECAPSULE50012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNb0e0243e-59b3-4f73-8c21-86b60fc7894b12
205323celecoxib 200 MG Oral CapsulePSNb0e0243e-59b3-4f73-8c21-86b60fc7894b12
349514celecoxib 400 MG Oral CapsulePSNb0e0243e-59b3-4f73-8c21-86b60fc7894b12
686379celecoxib 50 MG Oral CapsulePSNb0e0243e-59b3-4f73-8c21-86b60fc7894b12
205322celecoxib 100 MG Oral CapsuleSCDb0e0243e-59b3-4f73-8c21-86b60fc7894b12
205323celecoxib 200 MG Oral CapsuleSCDb0e0243e-59b3-4f73-8c21-86b60fc7894b12
349514celecoxib 400 MG Oral CapsuleSCDb0e0243e-59b3-4f73-8c21-86b60fc7894b12
686379celecoxib 50 MG Oral CapsuleSCDb0e0243e-59b3-4f73-8c21-86b60fc7894b12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60290-016-0160290001601100 CAPSULE in 1 BLISTER PACK (60290-016-01) 100 capsule2026-02-15NoNoCurrent
60290-016-026029000160260 CAPSULE in 1 BOTTLE (60290-016-02) 60 capsule2026-02-15NoNoCurrent
60290-016-0360290001603500 CAPSULE in 1 BOTTLE (60290-016-03) 500 capsule2026-02-15NoNoCurrent