HYZAAR
HYZAAR 50/12.5(LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS)HYZAAR 100/12.5(LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS)HYZAAR 100/25(LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS)
Approved
Approval ID
d7d7dcc9-c3e0-45e5-abcd-135a6d8c8dab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 2, 2012
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.
losartan potassium and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4341
Application NumberNDA020387
Product Classification
M
Marketing Category
C73594
G
Generic Name
losartan potassium and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2011
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
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
losartan potassium and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3866
Application NumberNDA020387
Product Classification
M
Marketing Category
C73594
G
Generic Name
losartan potassium and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2011
FDA Product Classification
INGREDIENTS (12)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
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
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
losartan potassium and hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5705
Application NumberNDA020387
Product Classification
M
Marketing Category
C73594
G
Generic Name
losartan potassium and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 12, 2011
FDA Product Classification
INGREDIENTS (10)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
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