FDA.reportPublic FDA data

Celecoxib

Product NDC
50268-168
11-digit product format
502680168
Labeler code
50268
Product ID
50268-168_5245a7d8-0271-b4bf-e063-6294a90a34a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA204519
Marketing category
ANDA
Marketing start
2019-10-17
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, 205323

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
50268-168-11Celecoxib1 in 1 BLISTER PACKCAPSULE16
50268-168-15Celecoxib50 in 1 BOXCAPSULE506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-168-11EA - Each50268-168dbba501f-fb85-48b5-80a5-9ec77d1c970d12019-11-12
50268-168-15EA - Each50268-168973aab93-7dc7-4563-9d97-4a9113b37e8112019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-168CELECOXIB CAPSULE [AVPAK]4Current NDC, Legacy NDC, 2 package rows20220507_951df0f7-5fb7-40f5-e053-2995a90a1edd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSN951df0f7-5fb7-40f5-e053-2995a90a1edd6
205323celecoxib 200 MG Oral CapsulePSN951df0f7-5fb7-40f5-e053-2995a90a1edd6
205322celecoxib 100 MG Oral CapsuleSCD951df0f7-5fb7-40f5-e053-2995a90a1edd6
205323celecoxib 200 MG Oral CapsuleSCD951df0f7-5fb7-40f5-e053-2995a90a1edd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-168-11502680168111 in 1 BLISTER PACKHistorical
50268-168-155026801681550 BLISTER PACK in 1 BOX (50268-168-15) / 1 CAPSULE in 1 BLISTER PACK (50268-168-11) 50 blister pack2019-10-170000-00-00NoNoCurrent