FDA.reportPublic FDA data

NDC 80425-0281-01 - 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
80425-0281
Requested NDC
80425-0281-01
Package NDCs from labels
80425-0281-1, 80425-0281-2, 80425-0281-3, 80425-0281-4, 80425-0281-01
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
80425-0281-1Celecoxib30 in 1 BOTTLECAPSULE302
80425-0281-2Celecoxib60 in 1 BOTTLECAPSULE602
80425-0281-3Celecoxib90 in 1 BOTTLECAPSULE902
80425-0281-4Celecoxib180 in 1 BOTTLECAPSULE1802

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0281CELECOXIB CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 4 package rows20250102_f60394f5-fd69-929b-e053-2995a90a5793.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0281-1EA - Each80425-02818b98e410-0122-4e2a-8d92-b9c6c170253512023-04-07
80425-0281-2EA - Each80425-0281b47b8b85-db6d-497e-9e03-929c73f5cc5412023-04-07
80425-0281-3EA - Each80425-02815e59fc25-c69d-4393-9b9e-53b19559dca112023-04-07
80425-0281-4EA - Each80425-028151cbb905-70ab-413c-b149-2cf9383403cb12023-04-07

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 5 of 7 · 131 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBCranbury Pharmaceuticals, LLC933532fa-044a-48b1-bbe4-28062564f98a2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCaf73fea0-5cd1-0fa2-e053-2a95a90af8fc2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCaf9d962a-5469-2039-e053-2a95a90ad59f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCaf9da1f2-717b-32b6-e053-2995a90ae5852024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCb3545cfb-97c3-b896-e053-2a95a90a15a02024-12-31Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCc8ade384-2072-2cc2-e053-2a95a90ae7912024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCc1abc73e-c6ab-a0a5-e053-2a95a90a08172024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCf60394f5-fd69-929b-e053-2995a90a57932024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210628
ndc (package): 80425-0281-4
ndc (package): 80425-0281-2
ndc (package): 80425-0281-3
ndc (package): 80425-0281-1
ndc (product): 80425-0281
ndc11 (package): 80425028101
rxcui: 205323
spl id: 2a9ba8f4-6cea-e827-e063-6394a90a0300
spl set id: f60394f5-fd69-929b-e053-2995a90a5793
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCf8fdcc56-7a53-9a42-e053-6394a90a48d52024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCf8fdd580-09da-9c1c-e053-6394a90a47062024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBModavar Pharmaceuticals LLCb0f73074-f3d8-4812-8e64-f88a02869ed32024-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
celecoxibCELECOXIBTorrent Pharmaceuticals Limited862698b6-2cc9-4374-992d-024beae6eba32024-12-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBQuality Care Products, LLCfcf49d7f-8319-4051-b7ac-fe063268b39b2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBUnichem Pharmaceuticals (USA), Inc.0e8484a8-04a6-4be3-8c5c-1883b0490d532024-12-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
celecoxibCELECOXIBQuality Care Products LLCf0df546e-17c9-4e85-839d-336612d7b9e52024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
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

Reported adverse events (FAERS/openFDA)#

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