FDA.reportPublic FDA data

CELEBREX

Product NDC
21695-023
11-digit product format
216950023
Labeler code
21695
Product ID
21695-023_c4ec3cc2-8574-4134-970e-26a82c5dbc0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
NDA020998
Marketing category
NDA
Marketing start
1998-10-02
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
200 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bff1fbab-f4cc-4993-b7de-2b555ee5eb73Product name120220509
cc117a7e-1ef6-4866-90a7-ce0d190eef9aProduct name120200925
827beb42-45f2-95b8-6aa3-f35174375422Product name920160429

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-023-142019-09-24C16284748780-1934fe258-4a52-48b1-e053-8cdaa90a720aThese 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
21695-023-152019-09-24C16284748780-1934fe258-4a52-48b1-e053-8cdaa90a720aThese 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
21695-023-602019-09-24C16284748780-1934fe258-4a52-48b1-e053-8cdaa90a720aThese 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
21695-023-14CELEBREX14 in 1 BOTTLECAPSULE141
21695-023-15CELEBREX15 in 1 BOTTLECAPSULE151
21695-023-30CELEBREX30 in 1 BOTTLECAPSULE301
21695-023-60CELEBREX60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-023-14EA - Each21695-023358009b8-6c0f-4b0e-ab0c-dc56b09d61b612012-07-24
21695-023-15EA - Each21695-023dbecdc8f-62b4-4f55-98ac-1536a27e20c112012-07-24
21695-023-30EA - Each21695-0235ab7fb40-cc5c-431b-aea3-d164ad969f5f12012-07-24
21695-023-60EA - Each21695-0230c63a76d-1fa1-4172-bcaa-38a983264ea612012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-023CELEBREX (CELECOXIB) CAPSULE [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 4 package rows20091229_14e50e10-bbe0-4a2c-983a-19bfa79bdef7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213468CeleBREX 100 MG Oral CapsulePSN14e50e10-bbe0-4a2c-983a-19bfa79bdef71
213469CeleBREX 200 MG Oral CapsulePSN14e50e10-bbe0-4a2c-983a-19bfa79bdef71
205322celecoxib 100 MG Oral CapsulePSN14e50e10-bbe0-4a2c-983a-19bfa79bdef71
205323celecoxib 200 MG Oral CapsulePSN14e50e10-bbe0-4a2c-983a-19bfa79bdef71
213468celecoxib 100 MG Oral Capsule [Celebrex]SBD14e50e10-bbe0-4a2c-983a-19bfa79bdef71
213469celecoxib 200 MG Oral Capsule [Celebrex]SBD14e50e10-bbe0-4a2c-983a-19bfa79bdef71
205322celecoxib 100 MG Oral CapsuleSCD14e50e10-bbe0-4a2c-983a-19bfa79bdef71
205323celecoxib 200 MG Oral CapsuleSCD14e50e10-bbe0-4a2c-983a-19bfa79bdef71
213468Celebrex 100 MG Oral CapsuleSY14e50e10-bbe0-4a2c-983a-19bfa79bdef71
213469Celebrex 200 MG Oral CapsuleSY14e50e10-bbe0-4a2c-983a-19bfa79bdef71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-023-142169500231414 in 1 BOTTLEHistorical
21695-023-152169500231515 in 1 BOTTLEHistorical
21695-023-302169500233030 in 1 BOTTLEHistorical
21695-023-602169500236060 in 1 BOTTLEHistorical