OSELTAMIVIR PHOSPHATE
These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULES safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULES. OSELTAMIVIR PHOSPHATE Capsules, for oral use.Initial U.S. Approval: 1999
Approved
Approval ID
0e666061-1bfd-48cd-896b-ded8298a1847
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2022
Manufacturers
FDA
Zydus Pharmaceuticals USA Inc.
DUNS: 156861945
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
oseltamivir phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1008
Application NumberANDA208578
Product Classification
M
Marketing Category
C73584
G
Generic Name
oseltamivir phosphate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2022
FDA Product Classification
INGREDIENTS (11)
OSELTAMIVIR PHOSPHATEActive
Quantity: 30 mg in 1 1
Code: 4A3O49NGEZ
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
oseltamivir phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1010
Application NumberANDA208578
Product Classification
M
Marketing Category
C73584
G
Generic Name
oseltamivir phosphate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2022
FDA Product Classification
INGREDIENTS (14)
OSELTAMIVIR PHOSPHATEActive
Quantity: 75 mg in 1 1
Code: 4A3O49NGEZ
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
oseltamivir phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70710-1009
Application NumberANDA208578
Product Classification
M
Marketing Category
C73584
G
Generic Name
oseltamivir phosphate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2022
FDA Product Classification
INGREDIENTS (14)
OSELTAMIVIR PHOSPHATEActive
Quantity: 45 mg in 1 1
Code: 4A3O49NGEZ
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT