FDA.reportPublic FDA data

NDC 83301-0011-01 - 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
83301-0011
Requested NDC
83301-0011-01
Package NDCs from labels
83301-0011-1, 83301-0011-2, 83301-0011-3, 83301-0011-01
Manufacturer
Mullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd.
Effective date
2026-08-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Celecoxib - Mullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd.Mullan Pharmaceutical Inc. | CSPC Ouyi Pharmaceutical Co., Ltd.2026-08-19HUMAN PRESCRIPTION DRUG LABEL
Celecoxib - A-S Medication SolutionsA-S Medication Solutions2026-08-07HUMAN PRESCRIPTION DRUG LABEL
Celecoxib - Direct_RxDirect_Rx2026-04-17HUMAN PRESCRIPTION DRUG LABEL
Celecoxib - Preferred Pharmaceutical Inc.Preferred Pharmaceutical Inc.2026-03-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83301-0011-1Celecoxib100 in 1 BOTTLECAPSULE1003
83301-0011-2Celecoxib500 in 1 BOTTLECAPSULE5003
83301-0011-3Celecoxib30 in 1 BOTTLECAPSULE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83301-0011CELECOXIB CAPSULE [MULLAN PHARMACEUTICAL INC.]2Current NDC, 3 package rows20250425_643e177f-216d-4dfa-824a-7516a488304e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83301-0011-1EA - Each83301-0011f892d2c0-443b-4ef6-bff5-4c32e3f1dfe412025-03-04
83301-0011-2EA - Each83301-0011d8085f29-1314-4207-8471-f4b25fe1253d12025-03-04

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 55 of 287 · 5,736 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AshleyBelle Moisturizing Hand Sanitizer Bellini GlowETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da8a7b6-d147-87c3-e063-6394a90a784c2026-03-22WarningsExact identifier
unii: 3K9958V90M
SMART CARE HOT WHEELS SWEET PEA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.de908bc4-5c4b-4cd1-8c47-1489e957e8182026-03-20WarningsExact identifier
unii: 3K9958V90M
ALCOHOL PREP AWABSISOPROPYL ALCOHOL PATCHHenan Bingqing Yujie wipes Co., LTD2e67e417-4dba-73a2-e063-6294a90aa4b22026-03-20WarningsExact identifier
unii: 3K9958V90M
Smart Care SQUISHMALLOWS SWEET PEA HAND SANITIZERETHYL ALCOHOLAshtel Studios, Inc.50ed03d9-88d1-4930-9c7d-62082bf8ce952026-03-20WarningsExact identifier
unii: 3K9958V90M
Protect by HEALTHY SKIN LAB MD SUNSCREEN TINTED MOISTURIZERTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED4a1ec566-549f-45f2-a43d-dacfc72633612026-03-20WarningsExact identifier
unii: 15FIX9V2JP
HAND SANITIZER MADRID MUSEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5cecf6-c232-6cd9-e063-6394a90a03e92026-03-19WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER VALENCIA VIBESALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5de4d6-4c58-f393-e063-6294a90a323a2026-03-19WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER MALLORCA BREEZEALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d5e50de-62fd-f9e9-e063-6394a90af0bd2026-03-19WarningsExact identifier
unii: 3K9958V90M
HAND SANITIZER MAR BELLAALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4d6005d9-5d4d-033e-e063-6294a90ad36f2026-03-19WarningsExact identifier
unii: 3K9958V90M
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCeca923da-59fa-da2e-e053-2a95a90a6a512026-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210071
rxcui: 205323
unii: JCX84Q7J1L
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30SKNVcare, LLC4d67dfb4-3607-2af6-e063-6294a90ae01a2026-03-19WarningsExact identifier
unii: 15FIX9V2JP
hand sanitizerHAND SANITIZERShenzhen yuehaotong Technology Co., Ltd4d482f95-e192-3fef-e063-6294a90a6a402026-03-18WarningsExact identifier
unii: 3K9958V90M
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d3a36b9-7d60-01ac-e063-6294a90af4fb2026-03-18WarningsExact identifier
unii: 15FIX9V2JP
Avant 70% Alcohol GelALCOHOLB4 Soap LLC241f4334-2e88-4f7b-a0c7-c93da9f5086c2026-03-18WarningsExact identifier
unii: 3K9958V90M
CelecoxibCELECOXIBPreferred Pharmaceutical Inc.7f20976d-bed3-4a06-9aaf-f5b5240e4ce32026-03-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA210071
ndc (package): 68788-4095-6
ndc (package): 68788-4095-3
ndc (package): 68788-4095-9
ndc (product): 68788-4095
rxcui: 205322
spl id: 7f20976d-bed3-4a06-9aaf-f5b5240e4ce3
spl set id: 7f20976d-bed3-4a06-9aaf-f5b5240e4ce3
unii: JCX84Q7J1L
OSKIN New York Coffee BB Cream SPF 30TITANIUM DIOXIDE, OCTOCRYLENE, ZINC OXIDEO'Skin Studio NY29dae75a-4368-432a-9cf8-f0f021f09e292026-03-17WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Premier Plastic Surgery4d39b64c-2e27-afed-e063-6394a90a38122026-03-17WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC4d39ed7a-ca80-893c-e063-6294a90a03e72026-03-17WarningsExact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC4d3a0a92-b0de-a1ea-e063-6294a90a85082026-03-17WarningsExact identifier
unii: 15FIX9V2JP
MedPRIDEISOPROPYL ALCOHOLShield Line LLCf2177bd3-259d-4231-88b2-4a98e48e4df62026-03-17WarningsExact identifier
unii: ND2M416302

Reported adverse events (FAERS/openFDA)#

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