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 9 of 11 · 203 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 368GB5141J
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLC15d6ef4f-568d-9d3e-e063-6294a90ab04c2024-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E
CelecoxibCELECOXIBMedsource Pharmaceuticals14962aef-7609-b29a-e063-6394a90a53992024-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 368GB5141J
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
unii: FZ989GH94E
CelecoxibCELECOXIBBryant Ranch Prepack631154cd-8f61-41b2-a686-80edc711cdaa2024-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
GOODSENSE ARTIFICIAL TEARSPOLYVINYL ALCOHOLProficient Rx LPf29c792c-6cb2-449f-b97d-6304a58dec2a2024-02-01WarningsExact identifier
unii: FZ989GH94E
GoodSense Artifical TearsPOLYVINYL ALCOHOL, AND POVIDONEProficient Rx LPcd24da78-fd90-4a9c-8e5f-f7fc56ec0fc92024-02-01WarningsExact identifier
unii: FZ989GH94E
Sunmark Eye Drops Advanced Moisturizer/LubricantDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINEStrategic Sourcing Services LLC0daa4e39-0447-44b6-a7d7-370b12bf94512023-12-23WarningsExact identifier
unii: FZ989GH94E
Meijer Artificial TearsPOLYVINYL ALCOHOL, POVIDONEMeijer Distribution, Inc.9feb3eec-a36f-8fc7-e053-2a95a90adcd32023-12-22WarningsExact identifier
unii: FZ989GH94E
Meijer Advanced Redness and Irritation ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIMeijer Distribution, Inc.9fea6d7a-a2cd-d26e-e053-2995a90a15f82023-12-22WarningsExact identifier
unii: FZ989GH94E
Walgreens Eye Drops Advanced Relief 15mLDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCIWalgreen Company949f5560-fba7-2da8-e053-2995a90a23c22023-12-20WarningsExact identifier
unii: FZ989GH94E
Signature Care Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLBetter Living Brands LLC5d7228ce-f108-4cc2-9aec-8b4548c3a1552023-12-20WarningsExact identifier
unii: FZ989GH94E
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
unii: FZ989GH94E
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
unii: FZ989GH94E
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
unii: FZ989GH94E
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
unii: FZ989GH94E
HEB Advanced Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEHEB Grocery Company, LPf76281d6-3aea-349b-e053-6394a90afca22023-12-20WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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