FDA Product

Hydrochlorothiazide

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

Basic Information

Product Name

Hydrochlorothiazide

FDA Product Code

64125-130

Regulatory Information

NDC Product Code

64125-130

Application Number

ANDA040702

Marketing Category

C73584

Effective Date

August 21, 2012

Territorial Authority

USA

FDA Title

HYDROCHLOROTHIAZIDE TABLETS, USP Rx only

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

Manufacturer

Excellium Pharmaceutical Inc.

DUNS Number

011769192

Active Ingredients

HYDROCHLOROTHIAZIDE

Quantity: 50 mg in 1 1

Code: 0J48LPH2TH

Class Code: ACTIB

Inactive Ingredients

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

LACTOSE

Code: J2B2A4N98G

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

Active Moieties

HYDROCHLOROTHIAZIDE

Code: 0J48LPH2TH

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