FDA.reportPublic FDA data

Celecoxib

Product NDC
71335-0292
11-digit product format
713350292
Labeler code
71335
Product ID
71335-0292_c567dba5-7b29-45e6-a7b1-ec062ee0d928
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204197
Marketing category
ANDA
Marketing start
2015-06-03
Marketing end
2026-11-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Celecoxib

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
71335-0292-1Celecoxib30 in 1 BOTTLECAPSULE3010
71335-0292-2Celecoxib20 in 1 BOTTLECAPSULE2010
71335-0292-3Celecoxib60 in 1 BOTTLECAPSULE6010
71335-0292-4Celecoxib90 in 1 BOTTLECAPSULE9010
71335-0292-5Celecoxib120 in 1 BOTTLECAPSULE12010
71335-0292-6Celecoxib14 in 1 BOTTLECAPSULE1410
71335-0292-7Celecoxib10 in 1 BOTTLECAPSULE1010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0292-1EA - Each71335-029204d5df23-9792-49d3-92c5-41966d00834412018-07-03
71335-0292-3EA - Each71335-0292e5e2b83a-65ca-4204-8996-e917fd649e3512018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0292CELECOXIB CAPSULE [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 7 package rows20250221_d94849a7-1831-4319-982c-c6b20dc42038.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNd94849a7-1831-4319-982c-c6b20dc4203810
205322celecoxib 100 MG Oral CapsuleSCDd94849a7-1831-4319-982c-c6b20dc4203810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0292-17133502920130 CAPSULE in 1 BOTTLE (71335-0292-1) 30 capsule2018-06-072026-11-30NoNoCurrent
71335-0292-27133502920220 CAPSULE in 1 BOTTLE (71335-0292-2) 20 capsule2025-01-282026-11-30NoNoCurrent
71335-0292-37133502920360 CAPSULE in 1 BOTTLE (71335-0292-3) 60 capsule2018-02-142026-11-30NoNoCurrent
71335-0292-47133502920490 CAPSULE in 1 BOTTLE (71335-0292-4) 90 capsule2025-01-282026-11-30NoNoCurrent
71335-0292-571335029205120 CAPSULE in 1 BOTTLE (71335-0292-5) 120 capsule2025-01-282026-11-30NoNoCurrent
71335-0292-67133502920614 CAPSULE in 1 BOTTLE (71335-0292-6) 14 capsule2025-01-282026-11-30NoNoCurrent
71335-0292-77133502920710 CAPSULE in 1 BOTTLE (71335-0292-7) 10 capsule2025-01-282026-11-30NoNoHistorical