Amiloride Hydrochloride
AMILORIDE HYDROCHLORIDE TABLETS, USP
Approved
Approval ID
de12b6f3-3791-4d78-90e6-c487cf951738
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Sigmapharm Laboratories, LLC
DUNS: 556234636
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 Code42794-005
Application NumberANDA079133
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 10, 2023
Generic NameAmiloride Hydrochloride
INGREDIENTS (7)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
AMILORIDE HYDROCHLORIDE ANHYDROUSActive
Quantity: 5 mg in 1 1
Code: 7M458Q65S3
Classification: ACTIB