FDA.reportPublic FDA data

CELECOXIB

Product NDC
72162-2357
11-digit product format
721622357
Labeler code
72162
Product ID
72162-2357_874f6977-fcbf-4160-9810-97c2203cd00f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210628
Marketing category
ANDA
Marketing start
2020-09-03
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CELECOXIB
Listing expiration
2027-12-31

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
72162-2357-1CELECOXIB100 in 1 BOTTLECAPSULE100102
72162-2357-5CELECOXIB500 in 1 BOTTLECAPSULE500102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2357-5EA - Each72162-2357dc1d505f-335d-41bc-b593-f569e6297d9012024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2357CELECOXIB CAPSULE [BRYANT RANCH PREPACK]101Current NDC, 2 package rows20250309_47be1d99-eebb-42f9-80d9-291a024b1364.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN47be1d99-eebb-42f9-80d9-291a024b1364102
205323celecoxib 200 MG Oral CapsuleSCD47be1d99-eebb-42f9-80d9-291a024b1364102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2357-172162235701100 CAPSULE in 1 BOTTLE (72162-2357-1) 100 capsule2020-09-03NoNoHistorical
72162-2357-572162235705500 CAPSULE in 1 BOTTLE (72162-2357-5) 500 capsule2020-09-03NoNoHistorical