FDA.reportPublic FDA data

NDC 80425-0096-01 - 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
80425-0096
Requested NDC
80425-0096-01
Package NDCs from labels
80425-0096-3, 80425-0096-2, 80425-0096-1, 80425-0096-01
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
80425-0096-1Celecoxib30 in 1 BOTTLECAPSULE309
80425-0096-2Celecoxib60 in 1 BOTTLECAPSULE609
80425-0096-3Celecoxib90 in 1 BOTTLECAPSULE909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0096CELECOXIB CAPSULE [ADVANCED RX OF TENNESSEE, LLC]9Current NDC, Legacy NDC, 3 package rows20250101_b3545cfb-97c3-b896-e053-2a95a90a15a0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0096-1EA - Each80425-0096b2178a8e-0b27-40b9-bb3a-0d3428af866412023-03-13
80425-0096-2EA - Each80425-0096ef334fbf-58aa-4935-9fbb-77be75e8dbdc12023-03-13
80425-0096-3EA - Each80425-00962744e407-261b-41dd-83bb-0f9ddae465d312023-03-13

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 2 of 7 · 131 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
celecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.78d59905-4a78-4d9f-ac29-58790a5b3a922026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204590
rxcui: 205323
unii: JCX84Q7J1L
CELECOXIBCELECOXIBBryant Ranch Prepackfd569104-8243-48fa-8e93-5a08654ad6dd2026-05-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBRedpharm Drug5250529a-6a03-78a1-e063-6294a90a47f92026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.52572bfb-43f0-4b55-b1fd-231a05c8b83e2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBAvPAK951df0f7-5fb7-40f5-e053-2995a90a1edd2026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
rxcui: 205322
unii: JCX84Q7J1L
celecoxibCELECOXIBMacleods Pharmaceuticals Limitedd14aecf5-16e9-459a-bda4-4ca8f290796a2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204590
ndc (product): 33342-157
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
spl id: bab34b9b-3e23-475d-a538-c0e3fe08be49
spl set id: d14aecf5-16e9-459a-bda4-4ca8f290796a
unii: JCX84Q7J1L
CelecoxibCELECOXIBREMEDYREPACK INC.56d64558-1fad-420e-8fcd-7103cd0731272026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBST. MARY'S MEDICAL PARK PHARMACYed2093f6-1606-100a-e053-2995a90a5b952026-05-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBREMEDYREPACK INC.56127f57-7810-4f5d-a11d-e08fb2ed138b2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349514
unii: JCX84Q7J1L
CelecoxibCELECOXIBApotex Corp.a62612b3-9564-2b34-be59-6aa5ac53679c2026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBDirect_Rx4b2ffbdb-1847-d93b-e063-6394a90a06f52026-04-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBNorthwind Health Company, LLC0de7a6f8-baba-1fd0-e063-6394a90ad4342026-04-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CELECOXIBCELECOXIBREMEDYREPACK INC.d0ca85fa-8b80-4a48-a1a4-a1c181821c392026-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBST. MARY'S MEDICAL PARK PHARMACY4e57bd99-5b7a-c2c7-e063-6294a90afb8c2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBAiPing Pharmaceutical, Inc.89db0dec-3800-4d89-a765-24838f4d0c302026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBPreferred Pharmaceuticals Inc.b0839895-6a36-4e4f-9336-98632b60622a2026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBPreferred Pharmaceuticals, Inc.f2a5ffbd-49c4-4a97-867b-2b14a36750202026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
celecoxibCELECOXIBPreferred Pharmaceuticals Inc.a6000132-ac6c-4b61-a98a-8cc2dd84b3f02026-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204590
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBPreferred Pharmaceuticals, Inc.d35d9494-4190-41a8-80d4-c9d877c432e92026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
celecoxibCELECOXIBPreferred Pharmaceuticals, Inc.2fc74af6-4573-411d-9082-f3edd44a52a42026-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204590
rxcui: 205322
unii: JCX84Q7J1L

Reported adverse events (FAERS/openFDA)#

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