Losartan Potassium and Hydrochlorothiazide
These 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 useRx OnlyInitial U.S. Approval: 1995
Approved
Approval ID
e0b74a86-3d36-1af0-e538-41b45b8d2cc3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2023
Manufacturers
FDA
JUBILANT CADISTA PHARMACEUTICALS INC.
DUNS: 022490515
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-337
Application NumberANDA201845
Product Classification
M
Marketing Category
C73584
G
Generic Name
losartan potassium and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2019
FDA Product Classification
INGREDIENTS (12)
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Carnauba WaxInactive
Code: R12CBM0EIZ
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
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
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Hydroxypropyl Cellulose (1600000 Wamw)Inactive
Code: RFW2ET671P
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
D&c Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
losartan potassium and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-338
Application NumberANDA201845
Product Classification
M
Marketing Category
C73584
G
Generic Name
losartan potassium and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2019
FDA Product Classification
INGREDIENTS (10)
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
hydrochlorothiazideActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
losartan potassiumActive
Quantity: 100 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
Hydroxypropyl Cellulose (1600000 Wamw)Inactive
Code: RFW2ET671P
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Carnauba WaxInactive
Code: R12CBM0EIZ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
losartan potassium and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59746-339
Application NumberANDA201845
Product Classification
M
Marketing Category
C73584
G
Generic Name
losartan potassium and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJuly 31, 2019
FDA Product Classification
INGREDIENTS (12)
losartan potassiumActive
Quantity: 100 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
hydrochlorothiazideActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
Cellulose, MicrocrystallineInactive
Code: OP1R32D61U
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Hydroxypropyl Cellulose (1600000 Wamw)Inactive
Code: RFW2ET671P
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Carnauba WaxInactive
Code: R12CBM0EIZ
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
D&c Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT