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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42794-005
Application NumberANDA079133
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amiloride Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2023
FDA Product Classification
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