FDA.reportPublic FDA data

NDC 80425-0167-01 - 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
80425-0167
Requested NDC
80425-0167-01
Package NDCs from labels
80425-0167-2, 80425-0167-1, 80425-0167-01
Manufacturer
Advanced Rx Pharmacy 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 Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0167-1Celecoxib30 in 1 BOTTLECAPSULE307
80425-0167-2Celecoxib60 in 1 BOTTLECAPSULE607

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0167CELECOXIB CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 2 package rows20250101_c8ade384-2072-2cc2-e053-2a95a90ae791.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0167-1EA - Each80425-016738c85090-0fae-4c8a-a95f-f1159e081c5b12023-03-13
80425-0167-2EA - Each80425-0167e68c30fe-2235-428f-a756-dc3cc3db78a012023-03-13

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 3 of 7 · 131 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCeca923da-59fa-da2e-e053-2a95a90a6a512026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBPreferred Pharmaceutical Inc.7f20976d-bed3-4a06-9aaf-f5b5240e4ce32026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CELECOXIBCELECOXIBBryant Ranch Prepack47be1d99-eebb-42f9-80d9-291a024b13642026-03-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBAvet Pharmaceuticals Inc.4bc96d0c-b484-3cee-e063-6294a90a91932026-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBScieGen Pharmaceuticals, Inc.8709cbe7-3de1-4908-a0a9-53002bcee15b2026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CELECOXIBCELECOXIBDirect Rxac87b4f9-3f66-8cf7-e053-2995a90ade0f2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204590
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBSportpharm LLC528a6f12-9878-4005-8fc2-5997adbb287f2026-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
celecoxibCELECOXIBSportpharm LLC1ae11faa-5bbe-49b7-a4dd-b573c304cf662026-02-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204590
rxcui: 349514
unii: JCX84Q7J1L
CELECOXIBCELECOXIBUmedica Laboratories USA Inc.b0e0243e-59b3-4f73-8c21-86b60fc7894b2026-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CELECOXIBCELECOXIBQingdao BAHEAL Pharmaceutical Co., Ltd.87c16a33-5eb0-40b0-a020-ed924326f6972026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CELECOXIBCELECOXIBNIVAGEN PHARMACEUTICALS, INC.ae7943ab-b1fc-f08f-e053-2995a90a051e2026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CELECOXIBCELECOXIBNorthwind Health Company, LLCf874eddf-b2f3-6830-e053-6394a90ade7a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CELECOXIBCELECOXIBNorthwind Health Company, LLCf2a0db9f-174b-1603-e053-2995a90a79a32026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
celecoxibCELECOXIBNorthwind Health Company, LLCc213e224-c2fb-726e-e053-2a95a90a21c52026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204590
rxcui: 205323
unii: JCX84Q7J1L
CELECOXIBCELECOXIBNorthwind Health Company, LLCdabfb290-0a7f-3429-e053-2a95a90ae04c2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CELECOXIBCELECOXIBNorthwind Health Company, LLCdac05189-4acf-d6bb-e053-2a95a90a46a92026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBRedPharm Drug2fbaa580-f33a-417d-e063-6294a90ad7df2025-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBYiling Pharmaceutical, Inc.43979279-867b-4303-8f30-fc58ae75a0692025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBChartwell RX, LLCa99a67f3-ccaa-4d54-8922-d6dd30fba2742025-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBAlembic Pharmaceuticals Limited14e8d788-e44c-4a40-8678-25cf45fed4772025-09-18Boxed 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.