Amiloride Hydrochloride and Hydrochlorothiazide
Amiloride Hydrochloride and Hydrochlorothiazide Tablets, USP
Approved
Approval ID
8b2c581a-f955-4a8e-bf85-e768e903fd10
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2022
Manufacturers
FDA
Teva Pharmaceuticals USA, Inc.
DUNS: 001627975
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Amiloride Hydrochloride and Hydrochlorothiazide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0555-0483
Application NumberANDA071111
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amiloride Hydrochloride and Hydrochlorothiazide
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2022
FDA Product Classification
INGREDIENTS (9)
AMILORIDE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: FZJ37245UC
Classification: ACTIR
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROCHLOROTHIAZIDEActive
Quantity: 50 mg in 1 1
Code: 0J48LPH2TH
Classification: ACTIB
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT