CELECOXIB
These highlights do not include all the information needed to use CELECOXIB CAPSULES safely and effectively. See full prescribing information for CELECOXIB CAPSULES. CELECOXIB capsules, for oral use Initial U.S. Approval: 1998
Approved
Approval ID
87c16a33-5eb0-40b0-a020-ed924326f697
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 8, 2024
Manufacturers
FDA
Qingdao BAHEAL Pharmaceutical Co., Ltd.
DUNS: 546626586
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Celecoxib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70247-006
Application NumberANDA208856
Product Classification
M
Marketing Category
C73584
G
Generic Name
Celecoxib
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (13)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C RED NO. 7Inactive
Code: ECW0LZ41X8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
CELECOXIBActive
Quantity: 50 mg in 1 1
Code: JCX84Q7J1L
Classification: ACTIB
Celecoxib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70247-007
Application NumberANDA208856
Product Classification
M
Marketing Category
C73584
G
Generic Name
Celecoxib
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (13)
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
CELECOXIBActive
Quantity: 100 mg in 1 1
Code: JCX84Q7J1L
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Celecoxib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70247-008
Application NumberANDA208856
Product Classification
M
Marketing Category
C73584
G
Generic Name
Celecoxib
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (14)
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
CELECOXIBActive
Quantity: 200 mg in 1 1
Code: JCX84Q7J1L
Classification: ACTIB
Celecoxib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70247-009
Application NumberANDA208856
Product Classification
M
Marketing Category
C73584
G
Generic Name
Celecoxib
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 8, 2024
FDA Product Classification
INGREDIENTS (14)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
CELECOXIBActive
Quantity: 400 mg in 1 1
Code: JCX84Q7J1L
Classification: ACTIB
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT