LOSARTAN POTASSIUM
These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1995
Approved
Approval ID
9af29d03-7192-4585-8e5f-82474c190af7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 21, 2025
Manufacturers
FDA
Hisun Pharmaceuticals USA, Inc.
DUNS: 961628505
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LOSARTAN POTASSIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42658-104
Application NumberANDA204795
Product Classification
M
Marketing Category
C73584
G
Generic Name
LOSARTAN POTASSIUM
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2025
FDA Product Classification
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
LOSARTAN POTASSIUMActive
Quantity: 100 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
LOSARTAN POTASSIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42658-102
Application NumberANDA204795
Product Classification
M
Marketing Category
C73584
G
Generic Name
LOSARTAN POTASSIUM
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2025
FDA Product Classification
INGREDIENTS (10)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
LOSARTAN POTASSIUMActive
Quantity: 25 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
LOSARTAN POTASSIUM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42658-103
Application NumberANDA204795
Product Classification
M
Marketing Category
C73584
G
Generic Name
LOSARTAN POTASSIUM
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2025
FDA Product Classification
INGREDIENTS (10)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LOSARTAN POTASSIUMActive
Quantity: 50 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT