Amiloride Hydrochloride and Hydrochlorothiazide
Approved
Approval ID
71f5c703-94d4-49b0-9c2d-374b9cbcab85
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amiloride Hydrochloride and Hydrochlorothiazide
PRODUCT DETAILS
NDC Product Code54868-0667
Application NumberANDA073209
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 17, 2010
Generic NameAmiloride Hydrochloride and Hydrochlorothiazide
INGREDIENTS (8)
AMILORIDE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: FZJ37245UC
Classification: ACTIB
HYDROCHLOROTHIAZIDEActive
Quantity: 50 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT