CELEBREX
CELEBREX
Approved
Approval ID
a645dfcd-7343-4c79-af8b-1117e4a5b113
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 14, 2019
Manufacturers
FDA
Direct Rx
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CELEBREX
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-046
Application NumberNDA020998
Product Classification
M
Marketing Category
C73594
G
Generic Name
CELEBREX
Product Specifications
Route of AdministrationORAL
Effective DateOctober 14, 2019
FDA Product Classification
INGREDIENTS (7)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CELECOXIBActive
Quantity: 200 mg in 1 1
Code: JCX84Q7J1L
Classification: ACTIB