Oseltamivir Phosphate
Oseltamivir Phosphate for Oral Suspension
Approved
Approval ID
7c0923ad-80b0-4134-b44a-754ea599f356
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 5, 2021
Manufacturers
FDA
Cadila Healthcare Limited
DUNS: 918596198
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OSELTAMIVIR ACID
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1598
Application NumberANDA209113
Product Classification
M
Marketing Category
C73584
G
Generic Name
OSELTAMIVIR ACID
Product Specifications
Route of AdministrationORAL
Effective DateAugust 5, 2021
FDA Product Classification
INGREDIENTS (8)
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
OSELTAMIVIR PHOSPHATEActive
Quantity: 6 mg in 1 mL
Code: 4A3O49NGEZ
Classification: ACTIM
MONOSODIUM CITRATEInactive
Code: 68538UP9SE
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 8/5/2021
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1598-6
Oseltamivir Phosphate for Oral Suspension
6 mg/mL *
60 mL (usable volume after constitution)
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 8/5/2021