FDA.reportPublic FDA data

CELECOXIB

Product NDC
71335-2019
11-digit product format
713352019
Labeler code
71335
Product ID
71335-2019_e8598d52-7e7b-4811-89ea-fa57e27c4d30
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
100 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
CELECOXIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322

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
71335-2019-1CELECOXIB30 in 1 BOTTLECAPSULE30106
71335-2019-2CELECOXIB20 in 1 BOTTLECAPSULE20106
71335-2019-3CELECOXIB60 in 1 BOTTLECAPSULE60106
71335-2019-4CELECOXIB90 in 1 BOTTLECAPSULE90106
71335-2019-5CELECOXIB120 in 1 BOTTLECAPSULE120106
71335-2019-6CELECOXIB14 in 1 BOTTLECAPSULE14106
71335-2019-7CELECOXIB10 in 1 BOTTLECAPSULE10106
71335-2019-8CELECOXIB28 in 1 BOTTLECAPSULE28106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2019-1EA - Each71335-201960a10a41-7a70-4641-a8f2-765a5338e42412023-02-06
71335-2019-3EA - Each71335-201952836cc8-070e-4059-84f7-99e1f08429fc12022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2019CELECOXIB CAPSULE [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 8 package rows20250226_fd569104-8243-48fa-8e93-5a08654ad6dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNfd569104-8243-48fa-8e93-5a08654ad6dd106
205322celecoxib 100 MG Oral CapsuleSCDfd569104-8243-48fa-8e93-5a08654ad6dd106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2019-17133520190130 CAPSULE in 1 BOTTLE (71335-2019-1) 30 capsule2022-01-040000-00-00NoNoCurrent
71335-2019-27133520190220 CAPSULE in 1 BOTTLE (71335-2019-2) 20 capsule2025-01-300000-00-00NoNoCurrent
71335-2019-37133520190360 CAPSULE in 1 BOTTLE (71335-2019-3) 60 capsule2022-01-040000-00-00NoNoCurrent
71335-2019-47133520190490 CAPSULE in 1 BOTTLE (71335-2019-4) 90 capsule2025-01-300000-00-00NoNoCurrent
71335-2019-571335201905120 CAPSULE in 1 BOTTLE (71335-2019-5) 120 capsule2025-01-300000-00-00NoNoCurrent
71335-2019-67133520190614 CAPSULE in 1 BOTTLE (71335-2019-6) 14 capsule2025-01-300000-00-00NoNoCurrent
71335-2019-77133520190710 CAPSULE in 1 BOTTLE (71335-2019-7) 10 capsule2025-01-30NoNoCurrent
71335-2019-87133520190828 CAPSULE in 1 BOTTLE (71335-2019-8) 28 capsule2025-01-30NoNoCurrent