Tamiflu
These highlights do not include all the information needed to use TAMIFLU safely and effectively. See full prescribing information for TAMIFLU. TAMIFLU (oseltamivir phosphate) capsules TAMIFLU (oseltamivir phosphate) for oral suspension Initial U.S. Approval: 1999
Approved
Approval ID
1948cafd-b5b3-4212-9d5d-8c293b1baad5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-4476
Application NumberNDA021087
Product Classification
M
Marketing Category
C73594
G
Generic Name
oseltamivir phosphate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2011
FDA Product Classification
INGREDIENTS (12)
oseltamivir phosphateActive
Quantity: 75 mg in 1 1
Code: 4A3O49NGEZ
Classification: ACTIM
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
povidone K30Inactive
Code: U725QWY32X
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
sodium stearyl fumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ferric oxide yellowInactive
Code: EX438O2MRT
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
FD&C blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
oseltamivir phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6083
Application NumberNDA021087
Product Classification
M
Marketing Category
C73594
G
Generic Name
oseltamivir phosphate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2011
FDA Product Classification
INGREDIENTS (10)
sodium stearyl fumarateInactive
Code: 7CV7WJK4UI
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
oseltamivir phosphateActive
Quantity: 45 mg in 1 1
Code: 4A3O49NGEZ
Classification: ACTIM
starch, cornInactive
Code: O8232NY3SJ
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
povidone k30Inactive
Code: U725QWY32X
Classification: IACT
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C blue No. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Oseltamivir Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-6315
Application NumberNDA021246
Product Classification
M
Marketing Category
C73594
G
Generic Name
Oseltamivir Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2011
FDA Product Classification
INGREDIENTS (7)
Oseltamivir PhosphateActive
Quantity: 6 mg in 1 mL
Code: 4A3O49NGEZ
Classification: ACTIM
monosodium citrateInactive
Code: 68538UP9SE
Classification: IACT
sorbitolInactive
Code: 506T60A25R
Classification: IACT
xanthan gumInactive
Code: TTV12P4NEE
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
saccharin sodiumInactive
Code: SB8ZUX40TY
Classification: IACT