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
NDC Product Code42211-205
Application NumberNDA207233
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateApril 8, 2019
Generic Namemeloxicam
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
NDC Product Code42211-206
Application NumberNDA207233
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateApril 8, 2019
Generic Namemeloxicam
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