FDA.reportPublic FDA data

CELECOXIB

Product NDC
71335-1066
11-digit product format
713351066
Labeler code
71335
Product ID
71335-1066_d087cc80-d7dc-427f-bf6b-10c33d14a92a
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
71335-1066-0CELECOXIB15 in 1 BOTTLECAPSULE1510
71335-1066-1CELECOXIB30 in 1 BOTTLECAPSULE3010
71335-1066-2CELECOXIB60 in 1 BOTTLECAPSULE6010
71335-1066-3CELECOXIB90 in 1 BOTTLECAPSULE9010
71335-1066-4CELECOXIB14 in 1 BOTTLECAPSULE1410
71335-1066-5CELECOXIB20 in 1 BOTTLECAPSULE2010
71335-1066-6CELECOXIB10 in 1 BOTTLECAPSULE1010
71335-1066-7CELECOXIB180 in 1 BOTTLECAPSULE18010
71335-1066-8CELECOXIB28 in 1 BOTTLECAPSULE2810
71335-1066-9CELECOXIB56 in 1 BOTTLECAPSULE5610

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1066-1EA - Each71335-10662ee99455-6881-4640-9a38-0be1ac12516112021-08-05
71335-1066-2EA - Each71335-10662bdf8980-b03b-4029-9dfc-cf46853f876312021-09-07
71335-1066-3EA - Each71335-106687633b0e-d2df-4d1f-b19e-8d59c74ec40412023-10-16
71335-1066-6EA - Each71335-10666b2b5375-d825-4710-a080-09ec04fb021f12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1066CELECOXIB (CELECOXIB) CAPSULE [BRYANT RANCH PREPACK]10Current NDC, Legacy NDC, 10 package rows20250223_deeecba5-7a76-444b-a891-b00b1fb16d51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNdeeecba5-7a76-444b-a891-b00b1fb16d5110
205323celecoxib 200 MG Oral CapsuleSCDdeeecba5-7a76-444b-a891-b00b1fb16d5110

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1066-07133510660015 CAPSULE in 1 BOTTLE (71335-1066-0) 15 capsule2021-09-090000-00-00NoNoCurrent
71335-1066-17133510660130 CAPSULE in 1 BOTTLE (71335-1066-1) 30 capsule2019-02-080000-00-00NoNoCurrent
71335-1066-27133510660260 CAPSULE in 1 BOTTLE (71335-1066-2) 60 capsule2021-05-240000-00-00NoNoCurrent
71335-1066-37133510660390 CAPSULE in 1 BOTTLE (71335-1066-3) 90 capsule2019-04-170000-00-00NoNoCurrent
71335-1066-47133510660414 CAPSULE in 1 BOTTLE (71335-1066-4) 14 capsule2020-03-200000-00-00NoNoCurrent
71335-1066-57133510660520 CAPSULE in 1 BOTTLE (71335-1066-5) 20 capsule2022-05-060000-00-00NoNoCurrent
71335-1066-67133510660610 CAPSULE in 1 BOTTLE (71335-1066-6) 10 capsule2019-05-010000-00-00NoNoCurrent
71335-1066-771335106607180 CAPSULE in 1 BOTTLE (71335-1066-7) 180 capsule2025-01-290000-00-00NoNoCurrent
71335-1066-87133510660828 CAPSULE in 1 BOTTLE (71335-1066-8) 28 capsule2021-06-210000-00-00NoNoCurrent
71335-1066-97133510660956 CAPSULE in 1 BOTTLE (71335-1066-9) 56 capsule2025-01-290000-00-00NoNoCurrent