FDA Product

Chlorthalidone

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

Basic Information

Product Name

Chlorthalidone

FDA Product Code

16714-129

Regulatory Information

NDC Product Code

16714-129

Application Number

ANDA207813

Marketing Category

C73584

Effective Date

November 24, 2022

Territorial Authority

USA

FDA Title

CHLORTHALIDONE TABLETS, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerNorthstar Rx LLC.

DUNS Number

830546433

Active Ingredients

Quantity: 50 mg in 1 1

Code: Q0MQD1073Q

Class Code: ACTIB

Inactive Ingredients

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATO

Code: 5856J3G2A2

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

STEARIC ACID

Code: 4ELV7Z65AP

Class Code: IACT

Active Moieties

CHLORTHALIDONE

Code: Q0MQD1073Q

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