Amiloride Hydrochloride and Hydrochlorothiazide

Basic Information

Product Name

FDA Product Code

0555-0483

Regulatory Information

NDC Product Code

0555-0483

Application Number

ANDA071111

Marketing Category

C73584

Effective Date

December 27, 2022

Territorial Authority

USA

FDA Title

Amiloride Hydrochloride and Hydrochlorothiazide Tablets, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

AMILORIDE HYDROCHLORIDE

Quantity: 5 mg in 1 1

Code: FZJ37245UC

Class Code: ACTIR

HYDROCHLOROTHIAZIDE

Quantity: 50 mg in 1 1

Code: 0J48LPH2TH

Class Code: ACTIB

Inactive Ingredients

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

D&C YELLOW NO. 10 ALUMINUM LAKE

Code: CQ3XH3DET6

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

ALUMINUM OXIDE

Code: LMI26O6933

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MAGNESIUM OXIDE

Code: 3A3U0GI71G

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

Active Moieties

HYDROCHLOROTHIAZIDE

Code: 0J48LPH2TH

AMILORIDE

Code: 7DZO8EB0Z3

Basic Information

Regulatory Information

Company Information

Active Ingredients

Inactive Ingredients

CROSCARMELLOSE SODIUM

D&C YELLOW NO. 10 ALUMINUM LAKE

LACTOSE MONOHYDRATE

ALUMINUM OXIDE

MAGNESIUM STEARATE

MAGNESIUM OXIDE

CELLULOSE, MICROCRYSTALLINE

Active Moieties

HYDROCHLOROTHIAZIDE

AMILORIDE