NOXAFIL
These highlights do not include all the information needed to use NOXAFIL safely and effectively. See full prescribing information for NOXAFIL. NOXAFIL (posaconazole) injection, for intravenous use NOXAFIL (posaconazole) delayed-release tablets, for oral useNOXAFIL (posaconazole) oral suspensionNOXAFIL PowderMix (posaconazole) for delayed-release oral suspensionInitial U.S. Approval: 2006
Approved
Approval ID
b073b082-7b57-4423-8c06-4fd4263d6f84
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2023
Manufacturers
FDA
Merck Sharp & Dohme LLC
DUNS: 118446553
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
posaconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0085-1328
Application NumberNDA022003
Product Classification
M
Marketing Category
C73594
G
Generic Name
posaconazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2023
FDA Product Classification
INGREDIENTS (10)
posaconazoleActive
Quantity: 40 mg in 1 mL
Code: 6TK1G07BHZ
Classification: ACTIB
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
trisodium citrate dihydrateInactive
Code: B22547B95K
Classification: IACT
citric acid monohydrateInactive
Code: 2968PHW8QP
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
anhydrous dextroseInactive
Code: 5SL0G7R0OK
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
posaconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0085-4324
Application NumberNDA205053
Product Classification
M
Marketing Category
C73594
G
Generic Name
posaconazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2023
FDA Product Classification
INGREDIENTS (12)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive
Code: 6N003M473W
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
posaconazoleActive
Quantity: 100 mg in 1 1
Code: 6TK1G07BHZ
Classification: ACTIB
posaconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0085-2224
Application NumberNDA214770
Product Classification
M
Marketing Category
C73594
G
Generic Name
posaconazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 20, 2023
FDA Product Classification
INGREDIENTS (19)
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSInactive
Code: SX01TZO3QZ
Classification: IACT
POSACONAZOLEActive
Quantity: 300 mg in 1 1
Code: 6TK1G07BHZ
Classification: ACTIB
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)Inactive
Code: 6N003M473W
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM CITRATE, UNSPECIFIED FORMInactive
Code: 1Q73Q2JULR
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
CALCIUM SULFATE, UNSPECIFIED FORMInactive
Code: WAT0DDB505
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
posaconazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0085-4331
Application NumberNDA205596
Product Classification
M
Marketing Category
C73594
G
Generic Name
posaconazole
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 20, 2023
FDA Product Classification
INGREDIENTS (6)
BETADEX SULFOBUTYL ETHER SODIUMInactive
Code: 2PP9364507
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
posaconazoleActive
Quantity: 18 mg in 1 mL
Code: 6TK1G07BHZ
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT