CELECOXIB

Product NDC
61919-168
11-digit product format
619190168
Labeler code
61919
Product ID
61919-168_84183aa1-959e-44a6-8ac1-e0c9ad69b22f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CELECOXIB
Dosage form
CAPSULE
Route
ORAL
Labeler
DirectRX
Application
NDA020998
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-01-01
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
61919-168-102020-01-31C16284748780-19d75b9d1-2a30-f424-e053-dadaa90a57ceCELECOXIB
61919-168-302020-01-31C16284748780-19d75b9d1-2a30-f424-e053-dadaa90a57ceCELECOXIB
61919-168-602020-01-31C16284748780-19d75b9d1-2a30-f424-e053-dadaa90a57ceCELECOXIB

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-168-10CELECOXIB10 in 1 BOTTLECAPSULE101
61919-168-30CELECOXIB30 in 1 BOTTLECAPSULE301
61919-168-60CELECOXIB60 in 1 BOTTLECAPSULE601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-168-30EA - Each61919-168dc7f3a41-2279-45c4-8480-2f6d9aa9522c12015-11-12
61919-168-60EA - Each61919-1683a1ec242-5d7c-4e0b-8e1c-cbd5e73776a012015-11-12

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-168CELECOXIB CAPSULE [DIRECTRX]1Legacy NDC, 3 package rows20151026_1aae31e7-eb98-4535-9e09-286ee94d2ed6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
205323celecoxib 200 MG Oral CapsulePSN1aae31e7-eb98-4535-9e09-286ee94d2ed61
205323celecoxib 200 MG Oral CapsuleSCD1aae31e7-eb98-4535-9e09-286ee94d2ed61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-168-106191901681010 in 1 BOTTLEHistorical
61919-168-306191901683030 in 1 BOTTLEHistorical
61919-168-606191901686060 in 1 BOTTLEHistorical