FDA.reportPublic FDA data

CELECOXIB

Product NDC
72162-2380
11-digit product format
721622380
Labeler code
72162
Product ID
72162-2380_d0b9626f-a5fe-433b-a766-915ac52875a3
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
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
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
72162-2380-1CELECOXIB100 in 1 BOTTLECAPSULE100102
72162-2380-5CELECOXIB500 in 1 BOTTLECAPSULE500102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2380-1EA - Each72162-23804cc1e739-d13e-4192-b5ca-485079d7043012024-11-05
72162-2380-5EA - Each72162-23802c522227-3aa2-4c1f-9eab-c8b573398edb12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2380CELECOXIB (CELECOXIB) CAPSULE [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20250522_627abea5-e39a-4e4f-b1ab-4842ed8112e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN627abea5-e39a-4e4f-b1ab-4842ed8112e9102
205323celecoxib 200 MG Oral CapsuleSCD627abea5-e39a-4e4f-b1ab-4842ed8112e9102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2380-172162238001100 CAPSULE in 1 BOTTLE (72162-2380-1) 100 capsule2024-08-15NoNoHistorical
72162-2380-572162238005500 CAPSULE in 1 BOTTLE (72162-2380-5) 500 capsule2024-08-15NoNoHistorical