LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Losartan Potassium and Hydrohlorothiazide Tablet, Film Coated HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS safely and effectively. See full prescribing information for LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS. LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE tablets, for oral use Initial U.S. Approval: 1995
Approved
Approval ID
b4168479-09ec-402c-89cc-456bc8485017
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2023
Manufacturers
FDA
Granules Pharmaceuticals Inc.
DUNS: 079825711
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
PRODUCT DETAILS
NDC Product Code70010-188
Application NumberANDA218015
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 12, 2023
Generic NameLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
INGREDIENTS (9)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LOSARTAN POTASSIUMActive
Quantity: 100 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
PRODUCT DETAILS
NDC Product Code70010-187
Application NumberANDA218015
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 12, 2023
Generic NameLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
INGREDIENTS (10)
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LOSARTAN POTASSIUMActive
Quantity: 50 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
PRODUCT DETAILS
NDC Product Code70010-189
Application NumberANDA218015
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 12, 2023
Generic NameLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
INGREDIENTS (10)
HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 9XZ8H6N6OH
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
LOSARTAN POTASSIUMActive
Quantity: 100 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB