FDA.reportPublic FDA data

celecoxib

Product NDC
85766-030
11-digit product format
857660030
Labeler code
85766
Product ID
85766-030_4a16aad9-d46e-bf19-e063-6394a90a0326
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA204590
Marketing category
ANDA
Marketing start
2016-03-16
Substance
CELECOXIB
Active strength
400 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
CELECOXIB400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui349514

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
85766-030-00celecoxib100 in 1 BOTTLECAPSULE1002
85766-030-01celecoxib1 in 1 BOTTLECAPSULE12
85766-030-07celecoxib7 in 1 BOTTLECAPSULE72
85766-030-10celecoxib10 in 1 BOTTLECAPSULE102
85766-030-14celecoxib14 in 1 BOTTLECAPSULE142
85766-030-20celecoxib20 in 1 BOTTLECAPSULE202
85766-030-30celecoxib30 in 1 BOTTLECAPSULE302
85766-030-60celecoxib60 in 1 BOTTLECAPSULE602
85766-030-90celecoxib90 in 1 BOTTLECAPSULE902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349514celecoxib 400 MG Oral CapsulePSN1ae11faa-5bbe-49b7-a4dd-b573c304cf662
349514celecoxib 400 MG Oral CapsuleSCD1ae11faa-5bbe-49b7-a4dd-b573c304cf662

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-030-0085766003000100 CAPSULE in 1 BOTTLE (85766-030-00) 100 capsule2025-08-13NoNoCurrent
85766-030-01857660030011 CAPSULE in 1 BOTTLE (85766-030-01) 1 capsule2025-08-13NoNoCurrent
85766-030-07857660030077 CAPSULE in 1 BOTTLE (85766-030-07) 7 capsule2025-08-13NoNoCurrent
85766-030-108576600301010 CAPSULE in 1 BOTTLE (85766-030-10) 10 capsule2025-08-13NoNoCurrent
85766-030-148576600301414 CAPSULE in 1 BOTTLE (85766-030-14) 14 capsule2025-08-13NoNoCurrent
85766-030-208576600302020 CAPSULE in 1 BOTTLE (85766-030-20) 20 capsule2025-08-13NoNoCurrent
85766-030-308576600303030 CAPSULE in 1 BOTTLE (85766-030-30) 30 capsule2025-08-13NoNoCurrent
85766-030-608576600306060 CAPSULE in 1 BOTTLE (85766-030-60) 60 capsule2025-08-13NoNoCurrent
85766-030-908576600309090 CAPSULE in 1 BOTTLE (85766-030-90) 90 capsule2025-08-13NoNoCurrent