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 useInitial U.S. Approval: 1999
Approved
Approval ID
8ca926e0-4c3c-473f-9cd0-ff38032d6963
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 25, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oseltamivir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60219-1264
Application NumberANDA209093
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oseltamivir
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 26, 2022
FDA Product Classification
INGREDIENTS (14)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
OSELTAMIVIR PHOSPHATEActive
Quantity: 30 mg in 1 1
Code: 4A3O49NGEZ
Classification: ACTIM
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15
Classification: IACT
Oseltamivir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60219-1266
Application NumberANDA209093
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oseltamivir
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 26, 2022
FDA Product Classification
INGREDIENTS (15)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
OSELTAMIVIR PHOSPHATEActive
Quantity: 75 mg in 1 1
Code: 4A3O49NGEZ
Classification: ACTIM
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15
Classification: IACT
Oseltamivir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code60219-1265
Application NumberANDA209093
Product Classification
M
Marketing Category
C73584
G
Generic Name
Oseltamivir
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 26, 2022
FDA Product Classification
INGREDIENTS (14)
OSELTAMIVIR PHOSPHATEActive
Quantity: 45 mg in 1 1
Code: 4A3O49NGEZ
Classification: ACTIM
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
METHYL ALCOHOLInactive
Code: Y4S76JWI15
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT