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
NDC Product Code0555-0483
Application NumberANDA071111
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 27, 2022
Generic NameAmiloride Hydrochloride and Hydrochlorothiazide
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