FDA.reportPublic FDA data

CELECOXIB

Product NDC
69097-422
11-digit product format
690970422
Labeler code
69097
Product ID
69097-422_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
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
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
CELECOXIB100 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
69097-422-02CELECOXIB30 in 1 BOTTLECAPSULE3014
69097-422-07CELECOXIB100 in 1 BOTTLECAPSULE10014
69097-422-12CELECOXIB500 in 1 BOTTLECAPSULE50014
69097-422-19CELECOXIB10 in 1 BLISTER PACKCAPSULE1014
69097-422-21CELECOXIB10 in 1 CARTONCAPSULE1014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-422-07EA - Each69097-4220919c50b-e584-46c7-b243-1b6ce96a51a512016-04-04
69097-422-12EA - Each69097-422875e8ef0-96cd-483f-bdb3-3443eac62f3512016-04-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-422CELECOXIB CAPSULE [CIPLA USA INC.]14Current NDC, Legacy NDC, 5 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
205322celecoxib 100 MG Oral CapsulePSNc91e5933-1798-4096-9f08-fb1200e154e13
205322celecoxib 100 MG Oral CapsuleSCDc91e5933-1798-4096-9f08-fb1200e154e13
205322celecoxib 100 MG Oral CapsulePSNf874eddf-b2f3-6830-e053-6394a90ade7a2
205322celecoxib 100 MG Oral CapsuleSCDf874eddf-b2f3-6830-e053-6394a90ade7a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-422-026909704220230 CAPSULE in 1 BOTTLE (69097-422-02) 30 capsule2015-09-230000-00-00NoNoCurrent
69097-422-0769097042207100 CAPSULE in 1 BOTTLE (69097-422-07) 100 capsule2015-09-230000-00-00NoNoCurrent
69097-422-1269097042212500 CAPSULE in 1 BOTTLE (69097-422-12) 500 capsule2015-09-230000-00-00NoNoCurrent
69097-422-196909704221910 in 1 BLISTER PACKHistorical
69097-422-216909704222110 BLISTER PACK in 1 CARTON (69097-422-21) / 10 CAPSULE in 1 BLISTER PACK (69097-422-19) 10 blister pack2015-09-230000-00-00NoNoCurrent