CELECOXIB

Product NDC
61919-045
11-digit product format
619190045
Labeler code
61919
Product ID
61919-045_3f147b5e-e23a-1723-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
DIRECT RX
Application
NDA020998
Marketing category
NDA
Marketing start
2014-01-01
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-045-30CELECOXIB30 in 1 BOTTLECAPSULE3011
61919-045-60CELECOXIB60 in 1 BOTTLECAPSULE6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-045-30EA - Each61919-0457de55042-4380-458e-b7c1-232391ebf7a012016-11-08
61919-045-60EA - Each61919-045c2ce1210-7a3f-4739-bfbd-66d10f36ab6212016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELECOXIB CAPSULE [DIRECT RX]1
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELECOXIB CAPSULE [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELECOXIB CAPSULE [DIRECT RX]1
GELATININACTIVE INGREDIENT2G86QN327LCELECOXIB CAPSULE [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELECOXIB CAPSULE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELECOXIB CAPSULE [DIRECT RX]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELECOXIB CAPSULE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELECOXIB CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-045CELECOXIB CAPSULE [DIRECT RX]11Legacy NDC, 2 package rows20161018_d4a9aaeb-bd5e-4a69-b26d-4ede84cb4166.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205322celecoxib 100 MG Oral CapsulePSNd4a9aaeb-bd5e-4a69-b26d-4ede84cb416611
205322celecoxib 100 MG Oral CapsuleSCDd4a9aaeb-bd5e-4a69-b26d-4ede84cb416611

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-045-306191900453030 in 1 BOTTLEHistorical
61919-045-606191900456060 in 1 BOTTLEHistorical