AMILORIDE HYDROCHLORIDE
Amiloride HCl Tablets, USP
Approved
Approval ID
1cf090a2-b6c0-42cd-857e-60a9cd85fe19
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2009
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5214
Application NumberNDA018200
Product Classification
M
Marketing Category
C73594
G
Generic Name
amiloride hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 22, 2011
FDA Product Classification
INGREDIENTS (3)
AMILORIDE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: FZJ37245UC
Classification: ACTIB
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT