FDA.reportPublic FDA data

Celecoxib

Product NDC
85766-009
11-digit product format
857660009
Labeler code
85766
Product ID
85766-009_4bdedcb2-33b7-6919-e063-6394a90a9563
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA205129
Marketing category
ANDA
Marketing start
2020-12-03
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
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
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
85766-009-00Celecoxib1000 in 1 BOTTLECAPSULE10005
85766-009-01Celecoxib1 in 1 BOTTLECAPSULE15
85766-009-05Celecoxib500 in 1 BOTTLECAPSULE5005
85766-009-07Celecoxib7 in 1 BOTTLECAPSULE75
85766-009-09Celecoxib10 in 1 BOTTLECAPSULE105
85766-009-10Celecoxib100 in 1 BOTTLECAPSULE1005
85766-009-14Celecoxib14 in 1 BOTTLECAPSULE145
85766-009-20Celecoxib20 in 1 BOTTLECAPSULE205
85766-009-30Celecoxib30 in 1 BOTTLECAPSULE305
85766-009-60Celecoxib60 in 1 BOTTLECAPSULE605
85766-009-90Celecoxib90 in 1 BOTTLECAPSULE905

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN528a6f12-9878-4005-8fc2-5997adbb287f5
205323celecoxib 200 MG Oral CapsuleSCD528a6f12-9878-4005-8fc2-5997adbb287f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-009-00857660009001000 CAPSULE in 1 BOTTLE (85766-009-00) 1000 capsule2025-06-20NoNoCurrent
85766-009-01857660009011 CAPSULE in 1 BOTTLE (85766-009-01) 1 capsule2025-06-20NoNoCurrent
85766-009-0585766000905500 CAPSULE in 1 BOTTLE (85766-009-05) 500 capsule2025-06-20NoNoCurrent
85766-009-07857660009077 CAPSULE in 1 BOTTLE (85766-009-07) 7 capsule2025-06-20NoNoCurrent
85766-009-098576600090910 CAPSULE in 1 BOTTLE (85766-009-09) 10 capsule2026-02-28NoNoCurrent
85766-009-1085766000910100 CAPSULE in 1 BOTTLE (85766-009-10) 100 capsule2025-06-20NoNoCurrent
85766-009-148576600091414 CAPSULE in 1 BOTTLE (85766-009-14) 14 capsule2025-06-20NoNoCurrent
85766-009-208576600092020 CAPSULE in 1 BOTTLE (85766-009-20) 20 capsule2025-06-20NoNoCurrent
85766-009-308576600093030 CAPSULE in 1 BOTTLE (85766-009-30) 30 capsule2025-06-20NoNoCurrent
85766-009-608576600096060 CAPSULE in 1 BOTTLE (85766-009-60) 60 capsule2025-06-20NoNoCurrent
85766-009-908576600099090 CAPSULE in 1 BOTTLE (85766-009-90) 90 capsule2025-06-20NoNoCurrent