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 7 of 11 · 203 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Soothing Eye Relief Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEWalgreens Co.29b7387b-ad65-3a11-e063-6394a90a6a152025-02-14WarningsExact identifier
unii: FZ989GH94E
CelecoxibCELECOXIBBryant Ranch Prepacka9749f00-0307-4842-a95b-9a8b4989df252025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CELECOXIBCELECOXIBBryant Ranch Prepack550c828b-8c88-4c47-a7b8-a436aed46dc72025-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CELECOXIBCELECOXIBBryant Ranch Prepackdeeecba5-7a76-444b-a891-b00b1fb16d512025-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBEPIC PHARMA, LLCac670924-0a3f-4f94-ac01-9e3c3071c9902025-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
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
application number: ANDA207446
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
application number: ANDA207446
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCf60394f5-fd69-929b-e053-2995a90a57932024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
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
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 368GB5141J
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

Reported adverse events (FAERS/openFDA)#

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