FDA.reportPublic FDA data

CELECOXIB

Product NDC
42571-145
11-digit product format
425710145
Labeler code
42571
Product ID
42571-145_350160e1-34ab-f7e3-e063-6394a90a4508
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA204776
Marketing category
ANDA
Marketing start
2018-06-01
Substance
CELECOXIB
Active strength
400 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
CELECOXIB400 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
42571-145-05CELECOXIB500 in 1 BOTTLECAPSULE50016
42571-145-60CELECOXIB60 in 1 BOTTLECAPSULE6016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-145-60EA - Each42571-145af924375-b6a3-4038-9718-f8a80ef6bd9e12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-145CELECOXIB (CELECOXIB) CAPSULE [MICRO LABS LIMITED]16Current NDC, Legacy NDC, 2 package rows20250515_408b30d6-f5c2-4239-b993-d8f77a8e160b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN408b30d6-f5c2-4239-b993-d8f77a8e160b16
205323celecoxib 200 MG Oral CapsulePSN408b30d6-f5c2-4239-b993-d8f77a8e160b16
349514celecoxib 400 MG Oral CapsulePSN408b30d6-f5c2-4239-b993-d8f77a8e160b16
686379celecoxib 50 MG Oral CapsulePSN408b30d6-f5c2-4239-b993-d8f77a8e160b16
205322celecoxib 100 MG Oral CapsuleSCD408b30d6-f5c2-4239-b993-d8f77a8e160b16
205323celecoxib 200 MG Oral CapsuleSCD408b30d6-f5c2-4239-b993-d8f77a8e160b16
349514celecoxib 400 MG Oral CapsuleSCD408b30d6-f5c2-4239-b993-d8f77a8e160b16
686379celecoxib 50 MG Oral CapsuleSCD408b30d6-f5c2-4239-b993-d8f77a8e160b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-145-0542571014505500 CAPSULE in 1 BOTTLE (42571-145-05) 500 capsule2018-06-010000-00-00NoNoCurrent
42571-145-604257101456060 CAPSULE in 1 BOTTLE (42571-145-60) 60 capsule2018-06-010000-00-00NoNoCurrent