FDA.reportPublic FDA data

CELECOXIB

Product NDC
71335-1804
11-digit product format
713351804
Labeler code
71335
Product ID
71335-1804_40e64c0a-b129-4059-8340-19a50b3278c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204776
Marketing category
ANDA
Marketing start
2018-06-01
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
71335-1804-1CELECOXIB30 in 1 BOTTLECAPSULE30106
71335-1804-2CELECOXIB20 in 1 BOTTLECAPSULE20106
71335-1804-3CELECOXIB60 in 1 BOTTLECAPSULE60106
71335-1804-4CELECOXIB90 in 1 BOTTLECAPSULE90106
71335-1804-5CELECOXIB120 in 1 BOTTLECAPSULE120106
71335-1804-6CELECOXIB14 in 1 BOTTLECAPSULE14106
71335-1804-7CELECOXIB10 in 1 BOTTLECAPSULE10106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1804-1EA - Each71335-1804072a1473-6315-4a2b-9fe8-a901851d917e12022-02-07
71335-1804-3EA - Each71335-1804283e4795-14b6-41c9-93b2-a8e037eee19e12022-04-06
71335-1804-4EA - Each71335-1804a70f4130-d017-4c39-a859-65377581a1f212024-01-04
71335-1804-5EA - Each71335-1804cdd48b24-eae6-423c-838c-8102231b522912022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1804CELECOXIB (CELECOXIB) CAPSULE [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 7 package rows20250226_550c828b-8c88-4c47-a7b8-a436aed46dc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN550c828b-8c88-4c47-a7b8-a436aed46dc7106
205322celecoxib 100 MG Oral CapsuleSCD550c828b-8c88-4c47-a7b8-a436aed46dc7106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1804-17133518040130 CAPSULE in 1 BOTTLE (71335-1804-1) 30 capsule2021-04-300000-00-00NoNoCurrent
71335-1804-27133518040220 CAPSULE in 1 BOTTLE (71335-1804-2) 20 capsule2025-01-300000-00-00NoNoCurrent
71335-1804-37133518040360 CAPSULE in 1 BOTTLE (71335-1804-3) 60 capsule2021-03-180000-00-00NoNoCurrent
71335-1804-47133518040490 CAPSULE in 1 BOTTLE (71335-1804-4) 90 capsule2022-07-280000-00-00NoNoCurrent
71335-1804-571335180405120 CAPSULE in 1 BOTTLE (71335-1804-5) 120 capsule2022-01-240000-00-00NoNoCurrent
71335-1804-67133518040614 CAPSULE in 1 BOTTLE (71335-1804-6) 14 capsule2025-01-300000-00-00NoNoCurrent
71335-1804-77133518040710 CAPSULE in 1 BOTTLE (71335-1804-7) 10 capsule2023-01-03NoNoHistorical