Dificid
These highlights do not include all the information needed to use DIFICID safely and effectively. See full prescribing information for DIFICID. DIFICID (fidaxomicin) tablets, for oral use DIFICID (fidaxomicin) for oral suspension Initial U.S. Approval: 2011
Approved
Approval ID
dd966338-c820-4270-b704-09ef75fa3ceb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 20, 2023
Manufacturers
FDA
Merck Sharp & Dohme LLC
DUNS: 118446553
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
FIDAXOMICIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52015-700
Application NumberNDA213138
Product Classification
M
Marketing Category
C73594
G
Generic Name
FIDAXOMICIN
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2022
FDA Product Classification
INGREDIENTS (8)
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
FIDAXOMICINActive
Quantity: 200 mg in 5 mL
Code: Z5N076G8YQ
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
fidaxomicin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52015-080
Application NumberNDA201699
Product Classification
M
Marketing Category
C73594
G
Generic Name
fidaxomicin
Product Specifications
Route of AdministrationORAL
Effective DateJune 7, 2022
FDA Product Classification
INGREDIENTS (12)
FIDAXOMICINActive
Quantity: 200 mg in 1 1
Code: Z5N076G8YQ
Classification: ACTIB
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT