Oseltamivir Phosphate
These highlights do not include all the information needed to use OSELTAMIVIR PHOSPHATE CAPSULE safely and effectively. See full prescribing information for OSELTAMIVIR PHOSPHATE CAPSULE. OSELTAMIVIR PHOSPHATE capsule, for oral useInitial U.S. Approval: 1999
Approved
Approval ID
f26154bd-374c-44a8-983a-b2724a591653
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2022
Manufacturers
FDA
Strides Pharma Science Limited
DUNS: 650738743
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 Code64380-798
Application NumberANDA209421
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oseltamivir Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2022
FDA Product Classification
INGREDIENTS (11)
OSELTAMIVIR PHOSPHATEActive
Quantity: 45 mg in 1 1
Code: 4A3O49NGEZ
Classification: ACTIM
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Oseltamivir Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64380-797
Application NumberANDA209421
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oseltamivir Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2022
FDA Product Classification
INGREDIENTS (12)
OSELTAMIVIR PHOSPHATEActive
Quantity: 30 mg in 1 1
Code: 4A3O49NGEZ
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Oseltamivir Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64380-799
Application NumberANDA209421
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oseltamivir Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 8, 2022
FDA Product Classification
INGREDIENTS (14)
OSELTAMIVIR PHOSPHATEActive
Quantity: 75 mg in 1 1
Code: 4A3O49NGEZ
Classification: ACTIM
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT