FDA.reportPublic FDA data

Celecoxib

Product NDC
72241-024
11-digit product format
722410024
Labeler code
72241
Product ID
72241-024_75f7a2cd-9aa3-4f66-a708-f3f6a8a571da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Modavar Pharmaceuticals LLC
Application
ANDA208701
Marketing category
ANDA
Marketing start
2021-08-23
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
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
CELECOXIB200 mg/1

Harmonized Identifiers#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
72241-024-03Celecoxib60 in 1 BOTTLECAPSULE604
72241-024-05Celecoxib100 in 1 BOTTLECAPSULE1004
72241-024-10Celecoxib500 in 1 BOTTLECAPSULE5004
72241-024-11Celecoxib1000 in 1 BOTTLECAPSULE10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72241-024-05EA - Each72241-024a326609e-e16e-4793-b6be-9ab5d7ea111112022-06-06
72241-024-10EA - Each72241-024fc0b9340-7383-4e84-961c-a91a6079189512022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72241-024CELECOXIB CAPSULE [MODAVAR PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 4 package rows20250108_b0f73074-f3d8-4812-8e64-f88a02869ed3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN1bf407db-8bc6-4aea-8bcc-eaa4c24cb7a6100
205323celecoxib 200 MG Oral CapsuleSCD1bf407db-8bc6-4aea-8bcc-eaa4c24cb7a6100
205322celecoxib 100 MG Oral CapsulePSNb0f73074-f3d8-4812-8e64-f88a02869ed34
205323celecoxib 200 MG Oral CapsulePSNb0f73074-f3d8-4812-8e64-f88a02869ed34
349514celecoxib 400 MG Oral CapsulePSNb0f73074-f3d8-4812-8e64-f88a02869ed34
686379celecoxib 50 MG Oral CapsulePSNb0f73074-f3d8-4812-8e64-f88a02869ed34
205322celecoxib 100 MG Oral CapsuleSCDb0f73074-f3d8-4812-8e64-f88a02869ed34
205323celecoxib 200 MG Oral CapsuleSCDb0f73074-f3d8-4812-8e64-f88a02869ed34
349514celecoxib 400 MG Oral CapsuleSCDb0f73074-f3d8-4812-8e64-f88a02869ed34
686379celecoxib 50 MG Oral CapsuleSCDb0f73074-f3d8-4812-8e64-f88a02869ed34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72241-024-037224100240360 CAPSULE in 1 BOTTLE (72241-024-03) 60 capsule2021-08-230000-00-00NoNoCurrent
72241-024-0572241002405100 CAPSULE in 1 BOTTLE (72241-024-05) 100 capsule2021-08-230000-00-00NoNoCurrent
72241-024-1072241002410500 CAPSULE in 1 BOTTLE (72241-024-10) 500 capsule2021-08-230000-00-00NoNoCurrent
72241-024-11722410024111000 CAPSULE in 1 BOTTLE (72241-024-11) 1000 capsule2021-08-230000-00-00NoNoCurrent