Alinia
These highlights do not include all the information needed to use ALINIA safely and effectively. See full prescribing information for ALINIA. ALINIA® (nitazoxanide) tablets, for oral use ALINIA® (nitazoxanide) for oral suspension Initial U.S. Approval: 2002
Approved
Approval ID
56b1575a-dff4-4c5a-a159-2f858e7a0cb8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2023
Manufacturers
FDA
Romark Laboratories, L.C.
DUNS: 877685123
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nitazoxanide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67546-111
Application NumberNDA021497
Product Classification
M
Marketing Category
C73594
G
Generic Name
nitazoxanide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (14)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
NITAZOXANIDEActive
Quantity: 500 mg in 1 1
Code: SOA12P041N
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
nitazoxanide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67546-212
Application NumberNDA021498
Product Classification
M
Marketing Category
C73594
G
Generic Name
nitazoxanide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (12)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)Inactive
Code: 461P5CJN6T
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
NITAZOXANIDEActive
Quantity: 100 mg in 5 mL
Code: SOA12P041N
Classification: ACTIB