CELECOXIB

Product NDC
43063-669
11-digit product format
430630669
Labeler code
43063
Product ID
43063-669_3284fb4d-544b-d0dc-e063-6394a90a8af4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA207446
Marketing category
ANDA
Marketing start
2015-09-23
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
43063-669-10CELECOXIB10 in 1 BOTTLE, PLASTICCAPSULE1017
43063-669-14CELECOXIB14 in 1 BOTTLE, PLASTICCAPSULE1417
43063-669-20CELECOXIB20 in 1 BOTTLE, PLASTICCAPSULE2017
43063-669-30CELECOXIB30 in 1 BOTTLE, PLASTICCAPSULE3017
43063-669-60CELECOXIB60 in 1 BOTTLE, PLASTICCAPSULE6017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-669CELECOXIB CAPSULE [PD-RX PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 5 package rows20250413_3191c9dc-bfdf-0591-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN3191c9dc-bfdf-0591-e054-00144ff8d46c17
205323celecoxib 200 MG Oral CapsuleSCD3191c9dc-bfdf-0591-e054-00144ff8d46c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-669-104306306691010 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-10) 10 capsule2016-04-280000-00-00NoNoCurrent
43063-669-144306306691414 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-14) 14 capsule2016-04-280000-00-00NoNoCurrent
43063-669-204306306692020 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-20) 20 capsule2016-04-280000-00-00NoNoCurrent
43063-669-304306306693030 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-30) 30 capsule2016-04-280000-00-00NoNoCurrent
43063-669-604306306696060 CAPSULE in 1 BOTTLE, PLASTIC (43063-669-60) 60 capsule2016-04-280000-00-00NoNoCurrent