Losartan Potassium and Hydrochlorothiazide
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg
Approved
Approval ID
80ed0406-cf05-423e-b5e7-4e544a88b0ed
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 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 Code21695-966
Application NumberANDA090528
Product Classification
M
Marketing Category
C73584
G
Generic Name
Losartan Potassium and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 14, 2011
FDA Product Classification
INGREDIENTS (11)
HYDROCHLOROTHIAZIDEActive
Quantity: 12.5 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LOSARTAN POTASSIUMActive
Quantity: 100 mg in 1 1
Code: 3ST302B24A
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT