FDA.reportPublic FDA data

Celecoxib

Product NDC
42806-722
11-digit product format
428060722
Labeler code
42806
Product ID
42806-722_2b20721c-b138-1932-e063-6394a90ae66e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
EPIC PHARMA, LLC
Application
ANDA207872
Marketing category
ANDA
Marketing start
2020-10-16
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42806-722-012022-12-28C16284748780-1e4f33bdf-9b27-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
42806-722-052022-12-28C16284748780-1e4f33bdf-9b27-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
42806-722-012022-07-29C16284748780-1e4f33bdf-9b27-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
42806-722-052022-07-29C16284748780-1e4f33bdf-9b27-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-722-01Celecoxib100 in 1 BOTTLECAPSULE1003
42806-722-05Celecoxib500 in 1 BOTTLECAPSULE5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-722CELECOXIB (CELECOXIB) CAPSULE [EPIC PHARMA, LLC]3Current NDC, Legacy NDC, 2 package rows20250109_ac670924-0a3f-4f94-ac01-9e3c3071c990.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNac670924-0a3f-4f94-ac01-9e3c3071c9903
205323celecoxib 200 MG Oral CapsulePSNac670924-0a3f-4f94-ac01-9e3c3071c9903
349514celecoxib 400 MG Oral CapsulePSNac670924-0a3f-4f94-ac01-9e3c3071c9903
686379celecoxib 50 MG Oral CapsulePSNac670924-0a3f-4f94-ac01-9e3c3071c9903
205322celecoxib 100 MG Oral CapsuleSCDac670924-0a3f-4f94-ac01-9e3c3071c9903
205323celecoxib 200 MG Oral CapsuleSCDac670924-0a3f-4f94-ac01-9e3c3071c9903
349514celecoxib 400 MG Oral CapsuleSCDac670924-0a3f-4f94-ac01-9e3c3071c9903
686379celecoxib 50 MG Oral CapsuleSCDac670924-0a3f-4f94-ac01-9e3c3071c9903

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-722-0142806072201100 CAPSULE in 1 BOTTLE (42806-722-01) 100 capsule2020-10-160000-00-00NoNoCurrent
42806-722-0542806072205500 CAPSULE in 1 BOTTLE (42806-722-05) 500 capsule2020-10-160000-00-00NoNoCurrent