CELECOXIB

Product NDC
69097-423
11-digit product format
690970423
Labeler code
69097
Product ID
69097-423_8df39b9c-af70-4ac3-ba9f-6e8e795ba961
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
Cipla USA Inc.
Application
ANDA207446
Marketing category
ANDA
Marketing start
2015-09-23
Substance
CELECOXIB
Active strength
50 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
CELECOXIB50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322, 205323, 349514, 686379

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
69097-423-02CELECOXIB30 in 1 BOTTLECAPSULE3014
69097-423-03CELECOXIB60 in 1 BOTTLECAPSULE6014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-423-03EA - Each69097-42311ae3c1f-7e24-4547-b81a-65fcac1cab9c12016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-423CELECOXIB CAPSULE [CIPLA USA INC.]14Current NDC, Legacy NDC, 2 package rows20250313_d12625b1-2af9-4532-af91-d40b65eeffef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNd12625b1-2af9-4532-af91-d40b65eeffef14
205323celecoxib 200 MG Oral CapsulePSNd12625b1-2af9-4532-af91-d40b65eeffef14
349514celecoxib 400 MG Oral CapsulePSNd12625b1-2af9-4532-af91-d40b65eeffef14
686379celecoxib 50 MG Oral CapsulePSNd12625b1-2af9-4532-af91-d40b65eeffef14
205322celecoxib 100 MG Oral CapsuleSCDd12625b1-2af9-4532-af91-d40b65eeffef14
205323celecoxib 200 MG Oral CapsuleSCDd12625b1-2af9-4532-af91-d40b65eeffef14
349514celecoxib 400 MG Oral CapsuleSCDd12625b1-2af9-4532-af91-d40b65eeffef14
686379celecoxib 50 MG Oral CapsuleSCDd12625b1-2af9-4532-af91-d40b65eeffef14

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-423-026909704230230 CAPSULE in 1 BOTTLE (69097-423-02) 30 capsule2015-09-230000-00-00NoNoCurrent
69097-423-036909704230360 CAPSULE in 1 BOTTLE (69097-423-03) 60 capsule2015-09-230000-00-00NoNoCurrent