N/A
These highlights do not include all the information needed to use NITAZOXANIDE TABLETS safely and effectively. See full prescribing information for NITAZOXANIDE TABLETS . NITAZOXANIDE tablets, for oral use Initial U.S. Approval: 2002
Approved
Approval ID
ba841705-1483-4823-e053-2995a90ae9ce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2023
Manufacturers
FDA
Lupin Pharmaceuticals, Inc.
DUNS: 089153071
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
nitazoxanide
PRODUCT DETAILS
NDC Product Code43386-405
Application NumberNDA021497
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateDecember 5, 2023
Generic Namenitazoxanide
INGREDIENTS (14)
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
NITAZOXANIDEActive
Quantity: 500 mg in 1 1
Code: SOA12P041N
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT