Amiloride Hydrochloride
Amiloride Hydrochloride Tablets
Approved
Approval ID
18d551a9-ffc7-4b14-adbd-92d84aa8e966
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 28, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code63629-2114
Application NumberANDA070346
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amiloride Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2021
FDA Product Classification
INGREDIENTS (7)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
AMILORIDE HYDROCHLORIDE ANHYDROUSActive
Quantity: 5 mg in 1 1
Code: 7M458Q65S3
Classification: ACTIB