FDA.reportPublic FDA data

NDC 80425-0040-01 - Celecoxib

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
80425-0040
Requested NDC
80425-0040-01
Package NDCs from labels
80425-0040-2, 80425-0040-1, 80425-0040-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Celecoxib - Advanced Rx of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0040-1Celecoxib30 in 1 BOTTLECAPSULE307
80425-0040-2Celecoxib60 in 1 BOTTLECAPSULE607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0040CELECOXIB CAPSULE [ADVANCED RX OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_af9da1f2-717b-32b6-e053-2995a90ae585.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0040-1EA - Each80425-004017418216-0c7a-4fea-b2f8-8197717daacd12023-03-13
80425-0040-2EA - Each80425-004076e24646-807b-4ec7-a5d7-a730484fd82e12023-03-13

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 7 of 7 · 131 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CELECOXIBCELECOXIBA-S Medication Solutionsc7a183dc-f4d5-483f-964c-f2745a3640ad2023-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204776
rxcui: 205322
unii: JCX84Q7J1L
celecoxibCELECOXIBA-S Medication Solutions85bfe02b-bfcb-44ee-81a0-11765c3054a92023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
celecoxibCELECOXIBProficient Rx LP0ad14a4e-2f05-4ce7-93d1-1cb7e4d8f7d02022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
celecoxibCELECOXIBProficient Rx LPcbd2d6de-6f0d-4b69-8e27-a1fe08830ba52022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBTianjin Tianyao Pharmaceuticals Co., Ltd.76f9bcb7-0e94-485f-816d-61d4e1ed24e02022-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBAphena Pharma Solutions - Tennessee, LLCd258e065-e9a6-44e2-89c9-6892d771d9d32021-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CELECOXIBCELECOXIBProficient Rx LPc91e5933-1798-4096-9f08-fb1200e154e12021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBProficient Rx LP6dd743d3-4821-4919-90eb-6d306ca7999f2021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
Celecoxib 200 mgCELECOXIBProficient Rx LPfeee6a01-63f9-42c3-8bd8-ca713a08b36d2019-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBProficient Rx LP7a234c0c-30a7-49f5-92a1-a1fc836ff9ae2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBProficient Rx LPc787b0ab-77ab-4f7e-9fea-be2a0085020a2019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L

Reported adverse events (FAERS/openFDA)#

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