FDA.reportPublic FDA data

Celecoxib

Product NDC
68788-8679
11-digit product format
687888679
Labeler code
68788
Product ID
68788-8679_39a398b1-faec-4f99-9ed7-c9444f41cfba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA210071
Marketing category
ANDA
Marketing start
2024-05-29
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
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
CELECOXIB200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205323

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
68788-8679-1Celecoxib100 in 1 BOTTLECAPSULE1003
68788-8679-3Celecoxib30 in 1 BOTTLECAPSULE303
68788-8679-6Celecoxib60 in 1 BOTTLECAPSULE603
68788-8679-8Celecoxib120 in 1 BOTTLECAPSULE1203
68788-8679-9Celecoxib90 in 1 BOTTLECAPSULE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8679-1EA - Each68788-86798d10fca3-71e4-4f7c-90cd-0a7c314e0cfe12024-07-12
68788-8679-3EA - Each68788-867990dcb073-99e2-4e9c-a52e-4ea678613e3512024-07-12
68788-8679-6EA - Each68788-8679dce92caf-14d1-4d75-bc06-664a2077632612024-07-12
68788-8679-8EA - Each68788-86792a22cb73-9331-41ed-ad87-612c217c91d112024-07-12
68788-8679-9EA - Each68788-8679a409517b-47cc-4e73-8052-eda8f1f7bab812024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8679CELECOXIB CAPSULE [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 5 package rows20250221_b0839895-6a36-4e4f-9336-98632b60622a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNb0839895-6a36-4e4f-9336-98632b60622a3
205323celecoxib 200 MG Oral CapsuleSCDb0839895-6a36-4e4f-9336-98632b60622a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8679-168788867901100 CAPSULE in 1 BOTTLE (68788-8679-1) 100 capsule2024-05-29NoNoHistorical
68788-8679-36878886790330 CAPSULE in 1 BOTTLE (68788-8679-3) 30 capsule2024-05-29NoNoHistorical
68788-8679-66878886790660 CAPSULE in 1 BOTTLE (68788-8679-6) 60 capsule2024-05-29NoNoHistorical
68788-8679-868788867908120 CAPSULE in 1 BOTTLE (68788-8679-8) 120 capsule2024-05-29NoNoHistorical
68788-8679-96878886790990 CAPSULE in 1 BOTTLE (68788-8679-9) 90 capsule2024-05-29NoNoHistorical