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 1 of 11 · 205 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
CelecoxibCELECOXIBMajor Pharmaceuticals3a1eadd5-c0a7-473e-bde0-6b9450d11c952026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBREMEDYREPACK INC.c96509cc-47f4-44f8-9f7e-4e49cc3d53482026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBDirectRxe0f3aacf-df5d-dad7-e053-2995a90ac5eb2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBA-S Medication Solutionse84d67c8-010d-495c-8691-ae16d0698f8d2026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBSt. Mary's Medical Park Pharmacy59f495e8-3cea-9d98-e063-6394a90a89d42026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
CelecoxibCELECOXIBMullan Pharmaceutical Inc.643e177f-216d-4dfa-824a-7516a488304e2026-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
rxcui: 205322
unii: JCX84Q7J1L
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
CelecoxibCELECOXIBREMEDYREPACK INC.b3acbfd9-a1c2-4aa6-b5f0-013cfad6cca82026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBREMEDYREPACK INC.e18d2fa4-4982-4e2a-af55-4319d6416efb2026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBA-S Medication Solutionsd799328f-9ea0-4b64-9667-8feaa97f150c2026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.b06ced10-81c6-4f48-a205-1e0db228cb8b2026-08-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBAlembic Pharmaceuticals Inc.806e5f8a-f986-4f88-ba3e-8265f86afa482026-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
rxcui: 205322
unii: JCX84Q7J1L
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
CELECOXIBCELECOXIBREMEDYREPACK INC.27f17ae7-939b-402e-9498-3b66111040892026-07-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBPD-Rx Pharmaceuticals, Inc.06076494-62ad-4f58-b8bb-7038fcfe3b122026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205323
unii: JCX84Q7J1L
CelecoxibCELECOXIBSt. Mary's Medical Park Pharmacy3bc74e76-0517-69c6-e063-6394a90abe752026-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 205322
unii: JCX84Q7J1L

Reported adverse events (FAERS/openFDA)#

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