FDA Product

DIURIL

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

DIURIL

FDA Product Code

65649-311

Regulatory Information

NDC Product Code

65649-311

Application Number

NDA011870

Marketing Category

C73594

Effective Date

November 1, 2021

Territorial Authority

USA

FDA Title

DIURIL® (chlorothiazide) Oral Suspension

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

23

Company Information

ManufacturerSalix Pharmaceuticals, Inc

DUNS Number

793108036

Active Ingredients

ALCOHOL

Code: 3K9958V90M

Class Code: IACT

Quantity: 250 mg in 5 mL

Code: 77W477J15H

Class Code: ACTIB

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

BENZOIC ACID

Code: 8SKN0B0MIM

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

TRAGACANTH

Code: 2944357O2O

Class Code: IACT

Active Moieties

CHLOROTHIAZIDE

Code: 77W477J15H

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