Losortan Potassium
Losartan Potassium Tablets, USP
Approved
Approval ID
41a61cf1-30a3-472b-a592-b17a610daaba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 21, 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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-989
Application NumberANDA078243
Product Classification
M
Marketing Category
C73584
G
Generic Name
Losartan Potassium
Product Specifications
Route of AdministrationORAL
Effective DateApril 20, 2011
FDA Product Classification
INGREDIENTS (12)
LOSARTAN POTASSIUMActive
Quantity: 25 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDInactive
Code: 2165RE0K14
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT