FDA.reportPublic FDA data

celecoxib

Product NDC
68788-7264
11-digit product format
687887264
Labeler code
68788
Product ID
68788-7264_e50df118-ab10-4beb-80eb-05c0453118bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204590
Marketing category
ANDA
Marketing start
2020-04-14
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
68788-7264-1celecoxib100 in 1 BOTTLECAPSULE1007
68788-7264-3celecoxib30 in 1 BOTTLECAPSULE307
68788-7264-6celecoxib60 in 1 BOTTLECAPSULE607
68788-7264-8celecoxib120 in 1 BOTTLECAPSULE1207
68788-7264-9celecoxib90 in 1 BOTTLECAPSULE907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7264-1EA - Each68788-726410c8cdca-2023-4051-b79b-dd63cb33832e12020-06-05
68788-7264-3EA - Each68788-7264650f842f-d9e2-4ced-86dc-6b33afb1744f12020-04-20
68788-7264-6EA - Each68788-726469bd87f8-5546-446c-8d96-83577ac1fe4e12020-04-20
68788-7264-9EA - Each68788-7264e9423a75-7448-4137-acae-b18ef269656412020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7264CELECOXIB CAPSULE [PREFERRED PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 5 package rows20250221_a6000132-ac6c-4b61-a98a-8cc2dd84b3f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSNa6000132-ac6c-4b61-a98a-8cc2dd84b3f07
205323celecoxib 200 MG Oral CapsuleSCDa6000132-ac6c-4b61-a98a-8cc2dd84b3f07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7264-168788726401100 CAPSULE in 1 BOTTLE (68788-7264-1) 100 capsule2020-04-140000-00-00NoNoCurrent
68788-7264-36878872640330 CAPSULE in 1 BOTTLE (68788-7264-3) 30 capsule2020-04-140000-00-00NoNoCurrent
68788-7264-66878872640660 CAPSULE in 1 BOTTLE (68788-7264-6) 60 capsule2020-04-140000-00-00NoNoCurrent
68788-7264-868788726408120 CAPSULE in 1 BOTTLE (68788-7264-8) 120 capsule2020-04-140000-00-00NoNoCurrent
68788-7264-96878872640990 CAPSULE in 1 BOTTLE (68788-7264-9) 90 capsule2020-04-140000-00-00NoNoCurrent