CELEBREX

Product NDC
58151-085
11-digit product format
581510085
Labeler code
58151
Product ID
58151-085_0c321a7b-89e4-48cc-ab0b-1bd7620d7799
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA020998
Marketing category
NDA
Marketing start
2023-09-12
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJCX84Q7J1L
Rxcui205322, 205323, 213468, 213469, 349514, 352314, 686379, 686381

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
58151-085-32CELEBREX1 in 1 BLISTER PACKCAPSULE113
58151-085-88CELEBREX100 in 1 CARTONCAPSULE10013
58151-085-91CELEBREX60 in 1 BOTTLECAPSULE6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-085-32EA - Each58151-085ba7ae262-1473-4750-aba9-e775659e125512025-05-14
58151-085-91EA - Each58151-0855928270b-0448-41fb-ae04-be6ffa5642bd12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-085CELEBREX (CELECOXIB) CAPSULE [VIATRIS SPECIALTY LLC]12Current NDC, 3 package rows20250210_2d6675e4-5859-4be2-8037-a20ce9f707aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213468CeleBREX 100 MG Oral CapsulePSN2d6675e4-5859-4be2-8037-a20ce9f707aa13
213469CeleBREX 200 MG Oral CapsulePSN2d6675e4-5859-4be2-8037-a20ce9f707aa13
352314CeleBREX 400 MG Oral CapsulePSN2d6675e4-5859-4be2-8037-a20ce9f707aa13
686381CeleBREX 50 MG Oral CapsulePSN2d6675e4-5859-4be2-8037-a20ce9f707aa13
205322celecoxib 100 MG Oral CapsulePSN2d6675e4-5859-4be2-8037-a20ce9f707aa13
205323celecoxib 200 MG Oral CapsulePSN2d6675e4-5859-4be2-8037-a20ce9f707aa13
349514celecoxib 400 MG Oral CapsulePSN2d6675e4-5859-4be2-8037-a20ce9f707aa13
686379celecoxib 50 MG Oral CapsulePSN2d6675e4-5859-4be2-8037-a20ce9f707aa13
213468celecoxib 100 MG Oral Capsule [Celebrex]SBD2d6675e4-5859-4be2-8037-a20ce9f707aa13
213469celecoxib 200 MG Oral Capsule [Celebrex]SBD2d6675e4-5859-4be2-8037-a20ce9f707aa13
352314celecoxib 400 MG Oral Capsule [Celebrex]SBD2d6675e4-5859-4be2-8037-a20ce9f707aa13
686381celecoxib 50 MG Oral Capsule [Celebrex]SBD2d6675e4-5859-4be2-8037-a20ce9f707aa13
205322celecoxib 100 MG Oral CapsuleSCD2d6675e4-5859-4be2-8037-a20ce9f707aa13
205323celecoxib 200 MG Oral CapsuleSCD2d6675e4-5859-4be2-8037-a20ce9f707aa13
349514celecoxib 400 MG Oral CapsuleSCD2d6675e4-5859-4be2-8037-a20ce9f707aa13
686379celecoxib 50 MG Oral CapsuleSCD2d6675e4-5859-4be2-8037-a20ce9f707aa13
213468Celebrex 100 MG Oral CapsuleSY2d6675e4-5859-4be2-8037-a20ce9f707aa13
213469Celebrex 200 MG Oral CapsuleSY2d6675e4-5859-4be2-8037-a20ce9f707aa13
352314Celebrex 400 MG Oral CapsuleSY2d6675e4-5859-4be2-8037-a20ce9f707aa13
686381Celebrex 50 MG Oral CapsuleSY2d6675e4-5859-4be2-8037-a20ce9f707aa13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58151-085-32581510085321 in 1 BLISTER PACKHistorical
58151-085-8858151008588100 BLISTER PACK in 1 CARTON (58151-085-88) / 1 CAPSULE in 1 BLISTER PACK (58151-085-32) 100 blister pack2023-10-11NoNoHistorical
58151-085-915815100859160 CAPSULE in 1 BOTTLE (58151-085-91) 60 capsule2023-09-12NoNoHistorical