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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
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