FDA.reportPublic FDA data

NDC 58151-083-32 - CELEBREX

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58151-083
Requested NDC
58151-083-32
Package NDCs from labels
58151-083-01, 58151-083-05, 58151-083-32, 58151-083-88
Manufacturer
Viatris Specialty LLC
Effective date
2024-11-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CELEBREX - Viatris Specialty LLCViatris Specialty LLC2024-11-22HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58151-083-01CELEBREX100 in 1 BOTTLECAPSULE10013
58151-083-05CELEBREX500 in 1 BOTTLECAPSULE50013
58151-083-32CELEBREX1 in 1 BLISTER PACKCAPSULE113
58151-083-88CELEBREX100 in 1 CARTONCAPSULE10013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-083CELEBREX (CELECOXIB) CAPSULE [VIATRIS SPECIALTY LLC]12Current NDC, 4 package rows20250210_2d6675e4-5859-4be2-8037-a20ce9f707aa.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-083-01EA - Each58151-0839cc744fe-7d1a-440d-ae7e-cdbc4912a36912024-10-04
58151-083-05EA - Each58151-08352728dd2-aef7-45b0-ba13-f2c92636319012024-10-04
58151-083-32EA - Each58151-0830658c01b-1cd4-407e-a0bb-b80e1dd3561c12024-10-04
58151-083-88EA - Each58151-083fa526296-e1a9-49d0-8182-fddb6a4ce37d12024-10-04

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 8 of 10 · 199 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBBryant Ranch Prepack0d89c39e-4858-4255-9127-1366e005203c2024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBBryant Ranch Prepack0dc9020d-28f5-4c69-896c-87b38e3ddb882024-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBAurobindo Pharma Limited1e811c3a-5653-4617-b958-380802cc443a2024-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBCadila Pharmaceuticals Limited78ce3df5-07ee-43bb-9348-104a9524a0322024-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBWestminster Pharmaceuticals, LLCcb0be640-067e-4422-9bec-d5fa07175bd02024-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
rxcui: 205322
unii: JCX84Q7J1L
ELYXYB - celecoxibCELECOXIBSCILEX PHARMACEUTICALS INC.c8a5de07-9f27-4a54-a885-8089f0307bd72024-11-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CELEBREXCELECOXIBViatris Specialty LLC2d6675e4-5859-4be2-8037-a20ce9f707aa2024-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: NDA020998
ndc (package): 58151-084-01
ndc (package): 58151-085-91
ndc (package): 58151-083-05
ndc (package): 58151-083-88
ndc (package): 58151-085-32
ndc (package): 58151-082-91
ndc (package): 58151-084-05
ndc (package): 58151-084-88
ndc (package): 58151-084-32
ndc (package): 58151-083-32
ndc (package): 58151-083-01
ndc (package): 58151-085-88
ndc (product): 58151-083
ndc (product): 58151-085
ndc (product): 58151-084
ndc (product): 58151-082
ndc11 (package): 58151008332
rxcui: 213468
rxcui: 686379
rxcui: 213469
rxcui: 205323
rxcui: 686381
rxcui: 352314
rxcui: 349514
rxcui: 205322
spl id: 0c321a7b-89e4-48cc-ab0b-1bd7620d7799
spl set id: 2d6675e4-5859-4be2-8037-a20ce9f707aa
unii: JCX84Q7J1L
CelecoxibCELECOXIBBryant Ranch Prepack1bf407db-8bc6-4aea-8bcc-eaa4c24cb7a62024-11-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBBryant Ranch Prepack8a1e9a52-4627-4098-8a11-25e92ad960232024-11-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
unii: FZ989GH94E
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 368GB5141J
CelecoxibCELECOXIBA-S Medication Solutions217265c0-e98e-482c-8af2-f8ac0ab7a0a12024-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CELECOXIBCELECOXIBProficient Rx LP1071fcb5-0e9f-4e30-8fb4-df76fd876fe82024-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBA-S Medication Solutions85b87dd2-c609-4d69-99eb-0acd852acdaf2024-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CELECOXIBCELECOXIBBryant Ranch Prepack627abea5-e39a-4e4f-b1ab-4842ed8112e92024-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBNuCare Pharmaceuticals,Inc.dfdc74e8-1e4e-53e1-e053-2995a90abc522024-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBNuCare Pharmaceuticals, Inc.1cbe21c0-3425-9a25-e063-6294a90a0d1d2024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
Artificial TearsPOLYVINYL ALCOHOL, POVIDONENuCare Pharmaceuticals,Inc.9c1c4911-908e-3c3c-e053-2995a90abcfc2024-06-14WarningsExact identifier
unii: FZ989GH94E
celecoxibCELECOXIBNuCare Pharmaceuticals,Inc.69aebbab-9906-be86-e053-2991aa0aa8a52024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBAsclemed USA, Inc.265b50cc-6d99-4ef8-8439-6792e1f21c682024-05-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.