OSELTAMIVIR
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
82685c2f-791b-440f-a1c2-5a032da7adca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2021
Manufacturers
FDA
Alembic Pharmaceuticals Inc.
DUNS: 079288842
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 Code62332-414
Application NumberANDA211823
Product Classification
M
Marketing Category
C73584
G
Generic Name
OSELTAMIVIR
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2021
FDA Product Classification
INGREDIENTS (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
OSELTAMIVIR PHOSPHATEActive
Quantity: 45 mg in 1 1
Code: 4A3O49NGEZ
Classification: ACTIM
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
OSELTAMIVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-413
Application NumberANDA211823
Product Classification
M
Marketing Category
C73584
G
Generic Name
OSELTAMIVIR
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2021
FDA Product Classification
INGREDIENTS (12)
OSELTAMIVIR PHOSPHATEActive
Quantity: 30 mg in 1 1
Code: 4A3O49NGEZ
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
OSELTAMIVIR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62332-415
Application NumberANDA211823
Product Classification
M
Marketing Category
C73584
G
Generic Name
OSELTAMIVIR
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2021
FDA Product Classification
INGREDIENTS (12)
OSELTAMIVIR PHOSPHATEActive
Quantity: 75 mg in 1 1
Code: 4A3O49NGEZ
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT