FDA.reportPublic FDA data

CELEBREX

Product NDC
21695-022
11-digit product format
216950022
Labeler code
21695
Product ID
21695-022_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
100 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
21695-022-002019-09-24C16284748780-1934fe258-4a52-48b1-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
21695-022-152019-09-24C16284748780-1934fe258-4a52-48b1-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
21695-022-302019-09-24C16284748780-1934fe258-4a52-48b1-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
21695-022-722019-09-24C16284748780-1934fe258-4a52-48b1-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
21695-022-00CELEBREX100 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 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

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 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
21695-022-0021695002200100 in 1 BOTTLEHistorical
21695-022-152169500221515 in 1 BOTTLEHistorical
21695-022-302169500223030 in 1 BOTTLEHistorical
21695-022-602169500226060 in 1 BOTTLEHistorical
21695-022-7221695002272120 in 1 BOTTLEHistorical