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 6 of 11 · 203 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
CelecoxibCELECOXIBAlembic Pharmaceuticals Limited14e8d788-e44c-4a40-8678-25cf45fed4772025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J
CELECOXIBCELECOXIBPHOENIX RX LLC3a669c28-fbc7-827c-e063-6394a90a08292025-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
VYSCOXACELECOXIBCarwin Pharmaceutical Associates, LLC5094d47e-f791-4190-9397-b7500143a74d2025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L
CelecoxibCELECOXIBPHOENIX RX LLC3a7b127e-c919-418f-e063-6394a90a06d02025-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBProficient Rx LP3a450db8-313c-4120-9b8e-58c956323fa42025-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CELECOXIBCELECOXIBA-S Medication Solutions95b2ced1-eca2-4c25-aa10-c9fb86b353a32025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207446
rxcui: 205323
unii: JCX84Q7J1L
CELECOXIBCELECOXIBA-S Medication Solutions7b8e923c-253f-461e-94d7-669e75dc73e92025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207446
rxcui: 205323
unii: JCX84Q7J1L
celecoxibCELECOXIBBryant Ranch Prepack351f5f07-bdd4-9893-e063-6394a90a72812025-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CELECOXIBCELECOXIBMicro Labs Limited408b30d6-f5c2-4239-b993-d8f77a8e160b2025-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBAsclemed USA, Inc.5d0dcac1-237c-47aa-bcfb-50fa20b5b8382025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
CELECOXIBCELECOXIBPD-Rx Pharmaceuticals, Inc.3191c9dc-bfdf-0591-e054-00144ff8d46c2025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207446
ndc (package): 43063-669-20
ndc (package): 43063-669-14
ndc (package): 43063-669-30
ndc (package): 43063-669-60
ndc (package): 43063-669-10
ndc (product): 43063-669
rxcui: 205323
spl id: 3284fb4d-544b-d0dc-e063-6394a90a8af4
spl set id: 3191c9dc-bfdf-0591-e054-00144ff8d46c
unii: JCX84Q7J1L
celecoxibCELECOXIBRedPharm Drug, Inc.50c29846-3426-0310-e054-00144ff8d46c2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CELECOXIBCELECOXIBQuallent Pharmaceuticals Health LLCaaa3a4f5-b281-415f-a08c-e0cefdae2fb52025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207446
rxcui: 205323
rxcui: 205322
unii: JCX84Q7J1L
CELECOXIBCELECOXIBCipla USA Inc.d12625b1-2af9-4532-af91-d40b65eeffef2025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207446
ndc (package): 69097-422-07
ndc (package): 69097-422-21
ndc (package): 69097-420-02
ndc (package): 69097-420-03
ndc (package): 69097-420-11
ndc (package): 69097-421-21
ndc (package): 69097-423-03
ndc (package): 69097-422-19
ndc (package): 69097-420-19
ndc (package): 69097-421-07
ndc (package): 69097-421-19
ndc (package): 69097-423-02
ndc (package): 69097-421-02
ndc (package): 69097-422-12
ndc (package): 69097-420-21
ndc (package): 69097-421-12
ndc (package): 69097-422-02
ndc (product): 69097-422
ndc (product): 69097-423
ndc (product): 69097-421
ndc (product): 69097-420
ndc11 (package): 69097042119
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
spl id: 8df39b9c-af70-4ac3-ba9f-6e8e795ba961
spl set id: d12625b1-2af9-4532-af91-d40b65eeffef
unii: JCX84Q7J1L
CELECOXIBCELECOXIBNorthStar RxLLCce61a585-5ac0-4185-99eb-a9511cd25a982025-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA207446
rxcui: 686379
rxcui: 205323
rxcui: 349514
rxcui: 205322
unii: JCX84Q7J1L
celecoxibCELECOXIBBryant Ranch Prepackac5c0d72-1bb3-4065-b2f4-5516b08697752025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBNCS HealthCare of KY, LLC dba Vangard Labs34bef49c-eca1-4f17-9b1b-55900ac408292025-02-20Boxed 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.