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amiloride hydrochloride

Amiloride Hydrochloride Tablets, USP Rx only

Approved
Approval ID

60e8e566-28c6-99ba-e053-2a91aa0a8dbe

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 13, 2021

Manufacturers
FDA

WINDLAS BIOTECH LIMITED

DUNS: 854248293

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 Code57721-671
Application NumberANDA204180
Product Classification
M
Marketing Category
C73584
G
Generic Name
amiloride hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 13, 2021
FDA Product Classification

INGREDIENTS (9)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
AMILORIDE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: FZJ37245UC
Classification: ACTIR
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT

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amiloride hydrochloride - FDA Drug Approval Details