FDA.reportPublic FDA data

Celecoxib

Product NDC
27808-296
11-digit product format
278080296
Labeler code
27808
Product ID
27808-296_2144dfb3-f0a5-4cb7-8957-1481c2ec28fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
Application
ANDA210071
Marketing category
ANDA
Marketing start
2024-12-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Celecoxib
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322, 205323, 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
27808-296-01Celecoxib100 in 1 BOTTLECAPSULE1005
27808-296-02Celecoxib500 in 1 BOTTLECAPSULE5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27808-296-01EA - Each27808-296ef0b1eab-05ab-486b-aeb3-fb547382f6e512025-02-10
27808-296-02EA - Each27808-2960d46f27b-4ced-4f62-a996-c88457a0986b12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-296CELECOXIB CAPSULE [CRANBURY PHARMACEUTICALS, LLC]5Current NDC, 2 package rows20250210_933532fa-044a-48b1-bbe4-28062564f98a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN933532fa-044a-48b1-bbe4-28062564f98a5
205323celecoxib 200 MG Oral CapsulePSN933532fa-044a-48b1-bbe4-28062564f98a5
686379celecoxib 50 MG Oral CapsulePSN933532fa-044a-48b1-bbe4-28062564f98a5
205322celecoxib 100 MG Oral CapsuleSCD933532fa-044a-48b1-bbe4-28062564f98a5
205323celecoxib 200 MG Oral CapsuleSCD933532fa-044a-48b1-bbe4-28062564f98a5
686379celecoxib 50 MG Oral CapsuleSCD933532fa-044a-48b1-bbe4-28062564f98a5
205322celecoxib 100 MG Oral CapsulePSN3bc74e76-0517-69c6-e063-6394a90abe753
205322celecoxib 100 MG Oral CapsuleSCD3bc74e76-0517-69c6-e063-6394a90abe753
205322celecoxib 100 MG Oral CapsulePSN7de31e90-2eaf-46cd-a058-3946b029d88c1
205322celecoxib 100 MG Oral CapsuleSCD7de31e90-2eaf-46cd-a058-3946b029d88c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
27808-296-0127808029601100 CAPSULE in 1 BOTTLE (27808-296-01) 100 capsule2024-12-01NoNoCurrent
27808-296-0227808029602500 CAPSULE in 1 BOTTLE (27808-296-02) 500 capsule2024-12-01NoNoCurrent