Celecoxib

Product NDC
11788-115
11-digit product format
117880115
Labeler code
11788
Product ID
11788-115_0978a0f1-be9d-4153-b9bc-9ab8652e8483
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
AiPing Pharmaceutical, Inc.
Application
ANDA208856
Marketing category
ANDA
Marketing start
2025-12-15
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
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
CELECOXIB400 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11788-115-60Celecoxib60 in 1 BOTTLECAPSULE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11788-115-60EA - Each11788-1152ca35cb6-2d42-4a84-8a07-08df2cba853a12026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN89db0dec-3800-4d89-a765-24838f4d0c303
205323celecoxib 200 MG Oral CapsulePSN89db0dec-3800-4d89-a765-24838f4d0c303
349514celecoxib 400 MG Oral CapsulePSN89db0dec-3800-4d89-a765-24838f4d0c303
686379celecoxib 50 MG Oral CapsulePSN89db0dec-3800-4d89-a765-24838f4d0c303
205322celecoxib 100 MG Oral CapsuleSCD89db0dec-3800-4d89-a765-24838f4d0c303
205323celecoxib 200 MG Oral CapsuleSCD89db0dec-3800-4d89-a765-24838f4d0c303
349514celecoxib 400 MG Oral CapsuleSCD89db0dec-3800-4d89-a765-24838f4d0c303
686379celecoxib 50 MG Oral CapsuleSCD89db0dec-3800-4d89-a765-24838f4d0c303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11788-115-601178801156060 CAPSULE in 1 BOTTLE (11788-115-60) 60 capsule2025-12-15NoNoCurrent