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
NDC Product Code63629-2114
Application NumberANDA070346
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 21, 2021
Generic NameAmiloride Hydrochloride
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