FDA.reportPublic FDA data

NDC 21695-022-60 - CELEBREX

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
21695-022
Requested NDC
21695-022-60
Package NDCs from labels
21695-022-15, 21695-022-30, 21695-022-60, 21695-022-00, 21695-022-72
Manufacturer
Rebel Distributors Corp.
Effective date
2009-07-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
CELEBREX - Rebel Distributors Corp.Rebel Distributors Corp.2009-07-10HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
21695-022-00These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules Initial U.S. Approval: 1998
21695-022-15These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules Initial U.S. Approval: 1998
21695-022-30These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules Initial U.S. Approval: 1998
21695-022-72These highlights do not include all the information needed to use CELEBREX safely and effectively. See full prescribing information for CELEBREX. CELEBREX ® (celecoxib) capsules Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-022-00CELEBREX100 in 1 BOTTLECAPSULE1001
21695-022-15CELEBREX15 in 1 BOTTLECAPSULE151
21695-022-30CELEBREX30 in 1 BOTTLECAPSULE301
21695-022-60CELEBREX60 in 1 BOTTLECAPSULE601
21695-022-72CELEBREX120 in 1 BOTTLECAPSULE1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-022CELEBREX (CELECOXIB) CAPSULE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 5 package rows20091229_14e50e10-bbe0-4a2c-983a-19bfa79bdef7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-022-00EA - Each21695-022edc5e31c-0363-4f3e-9efa-63b4a426567d12012-07-24
21695-022-15EA - Each21695-0224e3b8f8b-a059-4c49-8d8c-dfded331d3b212012-07-24
21695-022-30EA - Each21695-02267c7d420-4f16-4027-8732-b9cb21bd232712012-07-24
21695-022-60EA - Each21695-02269838c10-dd3c-41ad-80cc-b9452b0fec0e12012-07-24
21695-022-72EA - Each21695-022ea04f1c4-4f1d-46ad-829a-fb42fa8c336912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CelecoxibACTIVE INGREDIENTJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [REBEL DISTRIBUTORS CORP.]1
CelecoxibACTIVE MOIETYJCX84Q7J1LCELEBREX (CELECOXIB) CAPSULE [REBEL DISTRIBUTORS CORP.]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CELEBREX (CELECOXIB) CAPSULE [REBEL DISTRIBUTORS CORP.]1
gelatinINACTIVE INGREDIENT2G86QN327LCELEBREX (CELECOXIB) CAPSULE [REBEL DISTRIBUTORS CORP.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCELEBREX (CELECOXIB) CAPSULE [REBEL DISTRIBUTORS CORP.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CELEBREX (CELECOXIB) CAPSULE [REBEL DISTRIBUTORS CORP.]1
povidoneINACTIVE INGREDIENTFZ989GH94ECELEBREX (CELECOXIB) CAPSULE [REBEL DISTRIBUTORS CORP.]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JCELEBREX (CELECOXIB) CAPSULE [REBEL DISTRIBUTORS CORP.]1

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 10 · 200 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: 205323
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBHAWAII REPACK, INC.77f3b90b-a25d-4c47-975a-2a988d696a3f2026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
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: 205323
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
celecoxibCELECOXIBMacleods Pharmaceuticals Limitedd14aecf5-16e9-459a-bda4-4ca8f290796a2026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
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
CelecoxibCELECOXIBREMEDYREPACK INC.56127f57-7810-4f5d-a11d-e08fb2ed138b2026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JCX84Q7J1L

Reported adverse events (FAERS/openFDA)#

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