FDA.reportPublic FDA data

Celecoxib

Product NDC
71335-2222
11-digit product format
713352222
Labeler code
71335
Product ID
71335-2222_704cf8e0-c6c5-4426-b030-d0ad414ca3d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA205129
Marketing category
ANDA
Marketing start
2020-12-03
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
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
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
71335-2222-1Celecoxib30 in 1 BOTTLECAPSULE30103
71335-2222-2Celecoxib20 in 1 BOTTLECAPSULE20103
71335-2222-3Celecoxib60 in 1 BOTTLECAPSULE60103
71335-2222-4Celecoxib90 in 1 BOTTLECAPSULE90103
71335-2222-5Celecoxib120 in 1 BOTTLECAPSULE120103
71335-2222-6Celecoxib14 in 1 BOTTLECAPSULE14103
71335-2222-7Celecoxib10 in 1 BOTTLECAPSULE10103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2222-1EA - Each71335-2222225f6225-6585-443d-a805-ecde1da2db5b12025-03-04
71335-2222-4EA - Each71335-2222aa534bf8-3d78-4956-bf11-d20a93d0434f12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2222CELECOXIB CAPSULE [BRYANT RANCH PREPACK]103Current NDC, 7 package rows20241225_0dc9020d-28f5-4c69-896c-87b38e3ddb88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN0dc9020d-28f5-4c69-896c-87b38e3ddb88103
205322celecoxib 100 MG Oral CapsuleSCD0dc9020d-28f5-4c69-896c-87b38e3ddb88103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2222-17133522220130 CAPSULE in 1 BOTTLE (71335-2222-1) 30 capsule2023-09-19NoNoHistorical
71335-2222-27133522220220 CAPSULE in 1 BOTTLE (71335-2222-2) 20 capsule2024-10-18NoNoHistorical
71335-2222-37133522220360 CAPSULE in 1 BOTTLE (71335-2222-3) 60 capsule2023-08-30NoNoHistorical
71335-2222-47133522220490 CAPSULE in 1 BOTTLE (71335-2222-4) 90 capsule2024-05-06NoNoHistorical
71335-2222-571335222205120 CAPSULE in 1 BOTTLE (71335-2222-5) 120 capsule2024-12-11NoNoHistorical
71335-2222-67133522220614 CAPSULE in 1 BOTTLE (71335-2222-6) 14 capsule2024-12-11NoNoHistorical
71335-2222-77133522220710 CAPSULE in 1 BOTTLE (71335-2222-7) 10 capsule2024-02-09NoNoHistorical