Vivlodex
These highlights do not include all the information needed to use VIVLODEX™ safely and effectively. See full prescribing information for VIVLODEX. VIVLODEX (meloxicam) capsules, for oral use Initial U.S. Approval: 2000
Approved
Approval ID
fcfd6c24-98d0-4b7b-8336-936899ef61de
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 8, 2019
Manufacturers
FDA
Iroko Pharmaceuticals, LLC
DUNS: 796831217
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
meloxicam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42211-205
Application NumberNDA207233
Product Classification
M
Marketing Category
C73594
G
Generic Name
meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2019
FDA Product Classification
INGREDIENTS (10)
meloxicamActive
Quantity: 5 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PIGMENT RED 5Inactive
Code: 91OZU993LX
Classification: IACT
meloxicam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42211-206
Application NumberNDA207233
Product Classification
M
Marketing Category
C73594
G
Generic Name
meloxicam
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2019
FDA Product Classification
INGREDIENTS (11)
meloxicamActive
Quantity: 10 mg in 1 1
Code: VG2QF83CGL
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C Red NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C yellow NO. 6Inactive
Code: H77VEI93A8
Classification: IACT