FDA.reportPublic FDA data

Celecoxib

Product NDC
65862-909
11-digit product format
658620909
Labeler code
65862
Product ID
65862-909_5969bc02-84f8-41e5-a6b5-abcb6a985591
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA206827
Marketing category
ANDA
Marketing start
2016-02-01
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
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
65862-909-01Celecoxib100 in 1 BOTTLECAPSULE1009
65862-909-05Celecoxib500 in 1 BOTTLECAPSULE5009
65862-909-99Celecoxib1000 in 1 BOTTLECAPSULE10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-909-01EA - Each65862-909c1e1be1b-34e0-4f1a-b4a4-fefc0b5d11a612016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-909CELECOXIB CAPSULE [AUROBINDO PHARMA LIMITED]9Current NDC, Legacy NDC, 3 package rows20241215_1e811c3a-5653-4617-b958-380802cc443a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN1e811c3a-5653-4617-b958-380802cc443a9
205323celecoxib 200 MG Oral CapsulePSN1e811c3a-5653-4617-b958-380802cc443a9
349514celecoxib 400 MG Oral CapsulePSN1e811c3a-5653-4617-b958-380802cc443a9
686379celecoxib 50 MG Oral CapsulePSN1e811c3a-5653-4617-b958-380802cc443a9
205322celecoxib 100 MG Oral CapsuleSCD1e811c3a-5653-4617-b958-380802cc443a9
205323celecoxib 200 MG Oral CapsuleSCD1e811c3a-5653-4617-b958-380802cc443a9
349514celecoxib 400 MG Oral CapsuleSCD1e811c3a-5653-4617-b958-380802cc443a9
686379celecoxib 50 MG Oral CapsuleSCD1e811c3a-5653-4617-b958-380802cc443a9
205322celecoxib 100 MG Oral CapsulePSN34bef49c-eca1-4f17-9b1b-55900ac408291
205323celecoxib 200 MG Oral CapsulePSN03c40e1c-c274-48d9-9c70-5f2a670e49cc1
205323celecoxib 200 MG Oral CapsulePSN34bef49c-eca1-4f17-9b1b-55900ac408291
205322celecoxib 100 MG Oral CapsuleSCD34bef49c-eca1-4f17-9b1b-55900ac408291
205323celecoxib 200 MG Oral CapsuleSCD03c40e1c-c274-48d9-9c70-5f2a670e49cc1
205323celecoxib 200 MG Oral CapsuleSCD34bef49c-eca1-4f17-9b1b-55900ac408291

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65862-909-0165862090901100 CAPSULE in 1 BOTTLE (65862-909-01) 100 capsule2016-02-010000-00-00NoNoCurrent
65862-909-0565862090905500 CAPSULE in 1 BOTTLE (65862-909-05) 500 capsule2016-02-010000-00-00NoNoCurrent
65862-909-99658620909991000 CAPSULE in 1 BOTTLE (65862-909-99) 1000 capsule2016-02-010000-00-00NoNoCurrent