FDA.reportPublic FDA data

celecoxib

Product NDC
68788-7286
11-digit product format
687887286
Labeler code
68788
Product ID
68788-7286_a239d61d-8d19-4aa2-aa72-3ace64f849db
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA204590
Marketing category
ANDA
Marketing start
2016-03-16
Substance
CELECOXIB
Active strength
100 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
celecoxib
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322

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
68788-7286-3celecoxib30 in 1 BOTTLECAPSULE308
68788-7286-6celecoxib60 in 1 BOTTLECAPSULE608
68788-7286-9celecoxib90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7286-3EA - Each68788-72860bf871b6-571b-4ccb-8e64-762fe829663712020-04-20
68788-7286-6EA - Each68788-7286ef5d0305-3a19-44ab-9f68-48827284324212020-04-20
68788-7286-9EA - Each68788-72863f4a4945-cb28-450f-94d6-d4cbbfbcedab12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7286CELECOXIB CAPSULE [PREFERRED PHARMACEUTICALS, INC.]7Current NDC, Legacy NDC, 3 package rows20250221_2fc74af6-4573-411d-9082-f3edd44a52a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN2fc74af6-4573-411d-9082-f3edd44a52a48
205322celecoxib 100 MG Oral CapsuleSCD2fc74af6-4573-411d-9082-f3edd44a52a48

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7286-36878872860330 CAPSULE in 1 BOTTLE (68788-7286-3) 30 capsule2019-12-270000-00-00NoNoCurrent
68788-7286-66878872860660 CAPSULE in 1 BOTTLE (68788-7286-6) 60 capsule2019-12-270000-00-00NoNoCurrent
68788-7286-96878872860990 CAPSULE in 1 BOTTLE (68788-7286-9) 90 capsule2019-12-270000-00-00NoNoCurrent