CELEBREX

Product NDC
58151-084
11-digit product format
581510084
Labeler code
58151
Product ID
58151-084_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
2024-01-10
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
CELEBREX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CELECOXIB200 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
58151-084-01CELEBREX100 in 1 BOTTLECAPSULE10013
58151-084-05CELEBREX500 in 1 BOTTLECAPSULE50013
58151-084-32CELEBREX1 in 1 BLISTER PACKCAPSULE113
58151-084-88CELEBREX100 in 1 CARTONCAPSULE10013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-084-01EA - Each58151-084dd46cbde-6635-46e5-a38d-884f28f21dfb12024-02-14
58151-084-05EA - Each58151-08466b38e2c-ae7b-48ee-a399-79039af6644e12024-07-12
58151-084-32EA - Each58151-08472d95e78-0bed-4065-b8ef-64d8f199080212024-10-04
58151-084-88EA - Each58151-08460fd512a-c1aa-403a-81ec-b5b554c167ff12024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-084CELEBREX (CELECOXIB) CAPSULE [VIATRIS SPECIALTY LLC]12Current NDC, 4 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
58151-084-0158151008401100 CAPSULE in 1 BOTTLE (58151-084-01) 100 capsule2024-01-10NoNoHistorical
58151-084-0558151008405500 CAPSULE in 1 BOTTLE (58151-084-05) 500 capsule2024-06-20NoNoHistorical
58151-084-32581510084321 in 1 BLISTER PACKHistorical
58151-084-8858151008488100 BLISTER PACK in 1 CARTON (58151-084-88) / 1 CAPSULE in 1 BLISTER PACK (58151-084-32) 100 blister pack2024-08-30NoNoHistorical