amiloride hydrochloride
Amiloride HCl Tablets, USP
Approved
Approval ID
2b70cf0c-45be-428f-b396-5001ed4e30fc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2022
Manufacturers
FDA
Padagis US LLC
DUNS: 967694121
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 Code0574-0292
Application NumberNDA018200
Product Classification
M
Marketing Category
C73605
G
Generic Name
amiloride hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 30, 2022
FDA Product Classification
INGREDIENTS (5)
AMILORIDE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: FZJ37245UC
Classification: ACTIR
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT