HYZAAR
HYZAAR 50-12.5(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)HYZAAR 100-12.5 (LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)HYZAAR 100-25(LOSARTAN POTASSIUM-HYDROCHLOROTHIAZIDE TABLETS)
Approved
Approval ID
1ac2687d-1a70-4a69-b84c-22840925db09
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
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 Code21695-788
Application NumberNDA020387
Product Classification
M
Marketing Category
C73594
G
Generic Name
losartan potassium and hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateJune 28, 2007
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
hydrochlorothiazideActive
Quantity: 25 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
losartan potassiumActive
Quantity: 100 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT