CELEBREX

Product NDC
0025-1530
11-digit product format
000251530
Labeler code
0025
Product ID
0025-1530_aa50b33d-5037-4cd8-968a-b0f64f8fb490
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA020998
Marketing category
NDA
Marketing start
1998-10-02
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
400 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0025-1530-01EA - Each0025-1530b8f3f17d-520d-4935-9ba4-a974208bab8f12012-07-24
0025-1530-02EA - Each0025-1530bebf85b8-5ca7-4703-aad9-8a83f6df7e9312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [G.D. SEARLE LLC DIVISION OF PFIZER INC]16
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [G.D. SEARLE LLC DIVISION OF PFIZER INC]16
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELEBREX (CELECOXIB) CAPSULE [G.D. SEARLE LLC DIVISION OF PFIZER INC]16
GELATININACTIVE INGREDIENT2G86QN327LCELEBREX (CELECOXIB) CAPSULE [G.D. SEARLE LLC DIVISION OF PFIZER INC]16
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELEBREX (CELECOXIB) CAPSULE [G.D. SEARLE LLC DIVISION OF PFIZER INC]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELEBREX (CELECOXIB) CAPSULE [G.D. SEARLE LLC DIVISION OF PFIZER INC]16
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELEBREX (CELECOXIB) CAPSULE [G.D. SEARLE LLC DIVISION OF PFIZER INC]16
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELEBREX (CELECOXIB) CAPSULE [G.D. SEARLE LLC DIVISION OF PFIZER INC]16
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELEBREX (CELECOXIB) CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
GELATININACTIVE INGREDIENT2G86QN327LCELEBREX (CELECOXIB) CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELEBREX (CELECOXIB) CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELEBREX (CELECOXIB) CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELEBREX (CELECOXIB) CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELEBREX (CELECOXIB) CAPSULE [PHYSICIANS TOTAL CARE, INC.]5
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LCELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELEBREX (CELECOXIB) CAPSULE [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0025-1530CELEBREX (CELECOXIB) CAPSULE [PFIZER LABORATORIES DIV PFIZER INC]36Legacy NDC20250129_8d52185d-421f-4e34-8db7-f7676db2a226.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213468CeleBREX 100 MG Oral CapsulePSN73eb9256-dcda-4eb1-8a6e-700522146f2e5
213469CeleBREX 200 MG Oral CapsulePSN73eb9256-dcda-4eb1-8a6e-700522146f2e5
352314CeleBREX 400 MG Oral CapsulePSN73eb9256-dcda-4eb1-8a6e-700522146f2e5
205322celecoxib 100 MG Oral CapsulePSN73eb9256-dcda-4eb1-8a6e-700522146f2e5
205323celecoxib 200 MG Oral CapsulePSN73eb9256-dcda-4eb1-8a6e-700522146f2e5
349514celecoxib 400 MG Oral CapsulePSN73eb9256-dcda-4eb1-8a6e-700522146f2e5
213468celecoxib 100 MG Oral Capsule [Celebrex]SBD73eb9256-dcda-4eb1-8a6e-700522146f2e5
213469celecoxib 200 MG Oral Capsule [Celebrex]SBD73eb9256-dcda-4eb1-8a6e-700522146f2e5
352314celecoxib 400 MG Oral Capsule [Celebrex]SBD73eb9256-dcda-4eb1-8a6e-700522146f2e5
205322celecoxib 100 MG Oral CapsuleSCD73eb9256-dcda-4eb1-8a6e-700522146f2e5
205323celecoxib 200 MG Oral CapsuleSCD73eb9256-dcda-4eb1-8a6e-700522146f2e5
349514celecoxib 400 MG Oral CapsuleSCD73eb9256-dcda-4eb1-8a6e-700522146f2e5
213468Celebrex 100 MG Oral CapsuleSY73eb9256-dcda-4eb1-8a6e-700522146f2e5
213469Celebrex 200 MG Oral CapsuleSY73eb9256-dcda-4eb1-8a6e-700522146f2e5
352314Celebrex 400 MG Oral CapsuleSY73eb9256-dcda-4eb1-8a6e-700522146f2e5
213469CeleBREX 200 MG Oral CapsulePSN814511c9-89ef-42d7-912e-c00147833b7e1
205323celecoxib 200 MG Oral CapsulePSN814511c9-89ef-42d7-912e-c00147833b7e1
213469celecoxib 200 MG Oral Capsule [Celebrex]SBD814511c9-89ef-42d7-912e-c00147833b7e1
205323celecoxib 200 MG Oral CapsuleSCD814511c9-89ef-42d7-912e-c00147833b7e1
213469Celebrex 200 MG Oral CapsuleSY814511c9-89ef-42d7-912e-c00147833b7e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0025-1530-0100025153001100 BLISTER PACK in 1 CARTON (0025-1530-01) > 1 CAPSULE in 1 BLISTER PACK100 blister pack1998-10-020000-00-00NoNoCurrent
0025-1530-020002515300260 CAPSULE in 1 BOTTLE (0025-1530-02) 60 capsule1998-10-020000-00-00NoNoCurrent