Celecoxib

Product NDC
71209-057
11-digit product format
712090057
Labeler code
71209
Product ID
71209-057_491c8284-c565-4c6b-8d88-4373b179be4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Cadila Pharmaceuticals Limited
Application
ANDA208701
Marketing category
ANDA
Marketing start
2015-12-15
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
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
CELECOXIB400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322, 205323, 349514, 686379

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
71209-057-03Celecoxib60 in 1 BOTTLECAPSULE6014
71209-057-20Celecoxib600 in 1 BOTTLECAPSULE60014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71209-057CELECOXIB CAPSULE [CADILA PHARMACEUTICALS LIMITED]14Current NDC, Legacy NDC, 2 package rows20241212_78ce3df5-07ee-43bb-9348-104a9524a032.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN78ce3df5-07ee-43bb-9348-104a9524a03214
205323celecoxib 200 MG Oral CapsulePSN78ce3df5-07ee-43bb-9348-104a9524a03214
349514celecoxib 400 MG Oral CapsulePSN78ce3df5-07ee-43bb-9348-104a9524a03214
686379celecoxib 50 MG Oral CapsulePSN78ce3df5-07ee-43bb-9348-104a9524a03214
205322celecoxib 100 MG Oral CapsuleSCD78ce3df5-07ee-43bb-9348-104a9524a03214
205323celecoxib 200 MG Oral CapsuleSCD78ce3df5-07ee-43bb-9348-104a9524a03214
349514celecoxib 400 MG Oral CapsuleSCD78ce3df5-07ee-43bb-9348-104a9524a03214
686379celecoxib 50 MG Oral CapsuleSCD78ce3df5-07ee-43bb-9348-104a9524a03214

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71209-057-037120900570360 CAPSULE in 1 BOTTLE (71209-057-03) 60 capsule2018-08-230000-00-00NoNoCurrent
71209-057-2071209005720600 CAPSULE in 1 BOTTLE (71209-057-20) 600 capsule2018-08-230000-00-00NoNoCurrent