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 6 of 7 · 131 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
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
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
celecoxibCELECOXIBNuCare Pharmaceuticals,Inc.69aebbab-9906-be86-e053-2991aa0aa8a52024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204590
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
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLC15d6ef4f-568d-9d3e-e063-6294a90ab04c2024-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBMedsource Pharmaceuticals14962aef-7609-b29a-e063-6394a90a53992024-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBBryant Ranch Prepack631154cd-8f61-41b2-a686-80edc711cdaa2024-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
celecoxibCELECOXIBLupin Pharmaceuticals, Inc.560017b1-daf8-464e-b86f-0a75c78002ec2023-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBProficient Rx LPc529b321-38ed-434f-b76e-06902cdd40dc2023-12-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
celecoxibCELECOXIBAsclemed USA, Inc.2a926010-08e1-44dd-bc6d-ed15374bd0d32023-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA204590
rxcui: 205323
unii: JCX84Q7J1L
CELECOXIBCELECOXIBA-S Medication Solutions00e67d5e-df6f-4dfd-8c2d-a001c8a99af02023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBProficient Rx LPb9a7f32c-8136-4f29-be6b-4d5e904ca0f12023-05-01Boxed 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.