FDA.reportPublic FDA data

CELECOXIB

Product NDC
75834-237
11-digit product format
758340237
Labeler code
75834
Product ID
75834-237_482c41c4-9795-076e-e063-6394a90a3a85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
NIVAGEN PHARMACEUTICALS, INC.
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, 205323, 349514, 686379

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
75834-237-01CELECOXIB100 in 1 BOTTLECAPSULE10018
75834-237-05CELECOXIB500 in 1 BOTTLECAPSULE50018
75834-237-11CELECOXIB100 in 1 BLISTER PACKCAPSULE10018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-237CELECOXIB CAPSULE [NIVAGEN PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 3 package rows20250112_ae7943ab-b1fc-f08f-e053-2995a90a051e.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
205322celecoxib 100 MG Oral CapsulePSNae7943ab-b1fc-f08f-e053-2995a90a051e18
205323celecoxib 200 MG Oral CapsulePSNae7943ab-b1fc-f08f-e053-2995a90a051e18
349514celecoxib 400 MG Oral CapsulePSNae7943ab-b1fc-f08f-e053-2995a90a051e18
686379celecoxib 50 MG Oral CapsulePSNae7943ab-b1fc-f08f-e053-2995a90a051e18
205322celecoxib 100 MG Oral CapsuleSCDae7943ab-b1fc-f08f-e053-2995a90a051e18
205323celecoxib 200 MG Oral CapsuleSCDae7943ab-b1fc-f08f-e053-2995a90a051e18
349514celecoxib 400 MG Oral CapsuleSCDae7943ab-b1fc-f08f-e053-2995a90a051e18
686379celecoxib 50 MG Oral CapsuleSCDae7943ab-b1fc-f08f-e053-2995a90a051e18
205322celecoxib 100 MG Oral CapsulePSNd0ca85fa-8b80-4a48-a1a4-a1c181821c397
205322celecoxib 100 MG Oral CapsuleSCDd0ca85fa-8b80-4a48-a1a4-a1c181821c397
205322celecoxib 100 MG Oral CapsulePSN3a669c28-fbc7-827c-e063-6394a90a08292
205322celecoxib 100 MG Oral CapsuleSCD3a669c28-fbc7-827c-e063-6394a90a08292

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-237-0175834023701100 CAPSULE in 1 BOTTLE (75834-237-01) 100 capsule2020-09-030000-00-00NoNoCurrent
75834-237-0575834023705500 CAPSULE in 1 BOTTLE (75834-237-05) 500 capsule2020-09-030000-00-00NoNoCurrent
75834-237-1175834023711100 CAPSULE in 1 BLISTER PACK (75834-237-11) 100 capsule2020-09-030000-00-00NoNoCurrent