Celecoxib

Product NDC
63629-5503
11-digit product format
636295503
Labeler code
63629
Product ID
63629-5503_452bfda3-e71c-4523-94e8-99c328f22d77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Celecoxib
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA020998
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-12-10
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-5503-1EA - Each63629-5503957e0c17-4d6d-4b27-b676-eb948440a3d612015-10-02
63629-5503-2EA - Each63629-5503ee3eb908-f889-4a2a-9949-080b015a5cdc12015-10-02
63629-5503-3EA - Each63629-5503ea35d185-b8e9-4006-a8f3-652596bbb3ee12015-10-02
63629-5503-4EA - Each63629-550354827545-44f9-4393-acf4-94aeb6d4cf6812015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CELECOXIBACTIVE INGREDIENTJCX84Q7J1LCELECOXIB CAPSULE [BRYANT RANCH PREPACK]1001
CELECOXIBACTIVE MOIETYJCX84Q7J1LCELECOXIB CAPSULE [BRYANT RANCH PREPACK]1001
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CELECOXIB CAPSULE [BRYANT RANCH PREPACK]1001
GELATININACTIVE INGREDIENT2G86QN327LCELECOXIB CAPSULE [BRYANT RANCH PREPACK]1001
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCELECOXIB CAPSULE [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CELECOXIB CAPSULE [BRYANT RANCH PREPACK]1001
POVIDONESINACTIVE INGREDIENTFZ989GH94ECELECOXIB CAPSULE [BRYANT RANCH PREPACK]1001
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCELECOXIB CAPSULE [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-5503CELECOXIB CAPSULE [BRYANT RANCH PREPACK]1002Legacy NDC20240606_988113af-03cd-432e-8005-6a31005d97d2.zip