Celecoxib

Product NDC
85509-1158
11-digit product format
855091158
Labeler code
85509
Product ID
85509-1158_3a7b11a9-f0cd-d0d9-e063-6294a90a1b85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
PHOENIX RX LLC
Application
ANDA205129
Marketing category
ANDA
Marketing start
2020-12-03
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
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
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
85509-1158-1Celecoxib10 in 1 BOTTLECAPSULE101
85509-1158-3Celecoxib30 in 1 BOTTLECAPSULE301
85509-1158-6Celecoxib60 in 1 BOTTLECAPSULE601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN3a7b127e-c919-418f-e063-6394a90a06d01
205323celecoxib 200 MG Oral CapsuleSCD3a7b127e-c919-418f-e063-6394a90a06d01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85509-1158-18550911580110 CAPSULE in 1 BOTTLE (85509-1158-1) 10 capsule2025-07-31NoNoCurrent
85509-1158-38550911580330 CAPSULE in 1 BOTTLE (85509-1158-3) 30 capsule2025-07-31NoNoCurrent
85509-1158-68550911580660 CAPSULE in 1 BOTTLE (85509-1158-6) 60 capsule2025-07-31NoNoCurrent