FDA.reportPublic FDA data

NDC 69097-421-19 - 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
69097-421
Requested NDC
69097-421-19
Package NDCs from labels
69097-421-07, 69097-421-12, 69097-421-02, 69097-421-19, 69097-421-21
Manufacturer
REMEDYREPACK INC.
Effective date
2026-07-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CELECOXIB - REMEDYREPACK INC.REMEDYREPACK INC.2026-07-21HUMAN PRESCRIPTION DRUG LABEL
CELECOXIB - Medsource Pharmaceuticals | Cipla Limited- KurkumbhMedsource Pharmaceuticals | Cipla Limited- Kurkumbh2026-05-20HUMAN PRESCRIPTION DRUG LABEL
CELECOXIB - Northwind Health Company, LLCNorthwind Health Company, LLC2026-01-01HUMAN PRESCRIPTION DRUG LABEL
CELECOXIB - PD-Rx Pharmaceuticals, Inc.PD-Rx Pharmaceuticals, Inc.2025-04-11HUMAN PRESCRIPTION DRUG LABEL
CELECOXIB - Cipla USA Inc. | CIPLA LIMITED KURKUMBH | CIPLA LIMITED INDORECipla USA Inc. | CIPLA LIMITED KURKUMBH | CIPLA LIMITED INDORE2025-03-12HUMAN PRESCRIPTION DRUG LABEL
CELECOXIB - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2023-01-03HUMAN PRESCRIPTION DRUG LABEL
CELECOXIB - RedPharm Drug, Inc.RedPharm Drug, Inc.2022-01-21HUMAN PRESCRIPTION DRUG LABEL
CELECOXIB - A-S Medication SolutionsA-S Medication Solutions2018-01-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-421-02CELECOXIB30 in 1 BOTTLECAPSULE3014
69097-421-07CELECOXIB100 in 1 BOTTLECAPSULE10014
69097-421-12CELECOXIB500 in 1 BOTTLECAPSULE50014
69097-421-19CELECOXIB10 in 1 BLISTER PACKCAPSULE1014
69097-421-21CELECOXIB10 in 1 CARTONCAPSULE1014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-421CELECOXIB CAPSULE [CIPLA USA INC.]14Current NDC, Legacy NDC, 5 package rows20250313_d12625b1-2af9-4532-af91-d40b65eeffef.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-421-07EA - Each69097-421c42aa30f-1dee-4eb3-bad6-220ead35de2712016-04-04
69097-421-12EA - Each69097-421bb14d7e3-0d91-4d55-bc43-e2db9461b9e712016-04-04

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 11 · 203 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelecoxibCELECOXIBCardinal Health 107, LLCa9114d6a-13d7-443c-be44-7866b4a4cf962026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
celecoxibCELECOXIBHAWAII REPACK, INC.45816eae-ad83-4d2f-a035-c3f9f24708f92026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBHAWAII REPACK, INC.77f3b90b-a25d-4c47-975a-2a988d696a3f2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBSt Mary's Medical Park Pharmacye1ab644d-b668-3cf3-e053-2995a90addb02026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBRadha Pharmaceuticals, Inc.2c86ece8-1cf5-4688-91b1-8aef5d60b7e42026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBBryant Ranch Prepackd94849a7-1831-4319-982c-c6b20dc420382026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
celecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.78d59905-4a78-4d9f-ac29-58790a5b3a922026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
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
5247da09-38c7-beb9-e063-6294a90a4b4c12140b38-10c0-74f6-e063-6294a90a5a462026-05-20Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 5247da09-38c7-beb9-e063-6294a90a4b4c
spl set id: 12140b38-10c0-74f6-e063-6294a90a5a46
celecoxibCELECOXIBMacleods Pharmaceuticals Limitedd14aecf5-16e9-459a-bda4-4ca8f290796a2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
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
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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