Celecoxib

Product NDC
59762-1515
11-digit product format
597621515
Labeler code
59762
Product ID
59762-1515_094be167-4b68-4dd0-b996-8802dadf1fc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Greenstone LLC
Application
NDA020998
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-12-10
Marketing end
0000-00-00
Substance
CELECOXIB
Active strength
50 mg/1
Pharmacologic classes
Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-1515-1EA - Each59762-15156d4a1440-2601-4c05-80c1-5b900364a62b12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELECOXIB CAPSULE [GREENSTONE LLC]3
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELECOXIB CAPSULE [GREENSTONE LLC]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELECOXIB CAPSULE [GREENSTONE LLC]3
GELATININACTIVE INGREDIENT2G86QN327LCELECOXIB CAPSULE [GREENSTONE LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELECOXIB CAPSULE [GREENSTONE LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELECOXIB CAPSULE [GREENSTONE LLC]3
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELECOXIB CAPSULE [GREENSTONE LLC]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELECOXIB CAPSULE [GREENSTONE LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-1515CELECOXIB CAPSULE [MYLAN PHARMACEUTICALS INC.]11Legacy NDC20250502_12c2b345-bf1c-4661-85a8-257c4af2bda5.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-1515-15976215150160 CAPSULE in 1 BOTTLE (59762-1515-1) 60 capsule2014-12-100000-00-00NoNoCurrent