Cozaar
COZAAR (LOSARTAN POTASSIUM TABLETS)
Approved
Approval ID
9199238d-8b24-4ca8-bd24-c200853416f6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-2335
Application NumberNDA020386
Product Classification
M
Marketing Category
C73594
G
Generic Name
losartan potassium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2012
FDA Product Classification
INGREDIENTS (9)
losartan potassiumActive
Quantity: 100 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
losartan potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5077
Application NumberNDA020386
Product Classification
M
Marketing Category
C73594
G
Generic Name
losartan potassium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2012
FDA Product Classification
INGREDIENTS (9)
losartan potassiumActive
Quantity: 25 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
losartan potassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-3726
Application NumberNDA020386
Product Classification
M
Marketing Category
C73594
G
Generic Name
losartan potassium
Product Specifications
Route of AdministrationORAL
Effective DateOctober 1, 2012
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
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
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT