FDA.reportPublic FDA data

Celecoxib

Product NDC
72162-2421
11-digit product format
721622421
Labeler code
72162
Product ID
72162-2421_ee36adc1-dbb8-4415-965e-7ef6d3160cd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
Rxcui205323

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
72162-2421-1Celecoxib100 in 1 BOTTLECAPSULE100100
72162-2421-5Celecoxib500 in 1 BOTTLECAPSULE500100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2421-1EA - Each72162-24213a931913-14c2-4e7e-a724-53120c3b79d812025-01-14
72162-2421-5EA - Each72162-2421767d5a3d-846e-4b3c-b06d-db398956c1ac12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2421CELECOXIB CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 2 package rows20241113_1bf407db-8bc6-4aea-8bcc-eaa4c24cb7a6.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2421-172162242101100 CAPSULE in 1 BOTTLE (72162-2421-1) 100 capsule2024-11-11NoNoHistorical
72162-2421-572162242105500 CAPSULE in 1 BOTTLE (72162-2421-5) 500 capsule2024-11-11NoNoHistorical