FDA.reportPublic FDA data

Celecoxib

Product NDC
0591-3985
11-digit product format
005913985
Labeler code
0591
Product ID
0591-3985_3800c0c9-73b4-45a2-a2d4-7f33fd858b56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA200562
Marketing category
ANDA
Marketing start
2015-03-12
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

Additional Listing Data#

Finished product
No
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB400 mg/1

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
0591-3985-60Celecoxib60 in 1 BOTTLECAPSULE6021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3985-60EA - Each0591-3985d8809f0c-3e8a-443e-9361-c96feba4326512015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]5
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKCELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]5
GELATININACTIVE INGREDIENT2G86QN327LCELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]5
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-3985CELECOXIB CAPSULE [ACTAVIS PHARMA, INC.]20Legacy NDC, 1 package rows20250411_05224473-27dc-4f6d-a52a-c40a7af2f2f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN05224473-27dc-4f6d-a52a-c40a7af2f2f421
205323celecoxib 200 MG Oral CapsulePSN05224473-27dc-4f6d-a52a-c40a7af2f2f421
349514celecoxib 400 MG Oral CapsulePSN05224473-27dc-4f6d-a52a-c40a7af2f2f421
686379celecoxib 50 MG Oral CapsulePSN05224473-27dc-4f6d-a52a-c40a7af2f2f421
205322celecoxib 100 MG Oral CapsuleSCD05224473-27dc-4f6d-a52a-c40a7af2f2f421
205323celecoxib 200 MG Oral CapsuleSCD05224473-27dc-4f6d-a52a-c40a7af2f2f421
349514celecoxib 400 MG Oral CapsuleSCD05224473-27dc-4f6d-a52a-c40a7af2f2f421
686379celecoxib 50 MG Oral CapsuleSCD05224473-27dc-4f6d-a52a-c40a7af2f2f421
205322celecoxib 100 MG Oral CapsulePSN265b50cc-6d99-4ef8-8439-6792e1f21c681
205323celecoxib 200 MG Oral CapsulePSN265b50cc-6d99-4ef8-8439-6792e1f21c681
349514celecoxib 400 MG Oral CapsulePSN265b50cc-6d99-4ef8-8439-6792e1f21c681
686379celecoxib 50 MG Oral CapsulePSN265b50cc-6d99-4ef8-8439-6792e1f21c681
205322celecoxib 100 MG Oral CapsuleSCD265b50cc-6d99-4ef8-8439-6792e1f21c681
205323celecoxib 200 MG Oral CapsuleSCD265b50cc-6d99-4ef8-8439-6792e1f21c681
349514celecoxib 400 MG Oral CapsuleSCD265b50cc-6d99-4ef8-8439-6792e1f21c681
686379celecoxib 50 MG Oral CapsuleSCD265b50cc-6d99-4ef8-8439-6792e1f21c681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-3985-00005913985007860 CAPSULE in 1 CONTAINER (0591-3985-00)7860 capsule12-MAR-15Current
0591-3985-600059139856060 CAPSULE in 1 BOTTLE (0591-3985-60) 60 capsule2015-03-120000-00-00NoNoCurrent