Chlorpromazine Hydrochloride

Basic Information

Product Name

FDA Product Code

0781-4027

Regulatory Information

NDC Product Code

0781-4027

Application Number

ANDA214542

Marketing Category

C73584

Effective Date

April 3, 2023

Territorial Authority

USA

FDA Title

Chlorpromazine Hydrochloride Oral Concentrate, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

Chlorpromazine Hydrochloride

Quantity: 30 mg in 1 mL

Code: 9WP59609J6

Class Code: ACTIB

Edetate Disodium

Code: 7FLD91C86K

Class Code: IACT

Sodium Benzoate

Code: OJ245FE5EU

Class Code: IACT

ANHYDROUS CITRIC ACID

Code: XF417D3PSL

Class Code: IACT

SODIUM CITRATE, UNSPECIFIED FORM

Code: 1Q73Q2JULR

Class Code: IACT

Sucralose

Code: 96K6UQ3ZD4

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

CHLORPROMAZINE

Code: U42B7VYA4P

Basic Information

Regulatory Information

Company Information

Active Ingredients

Edetate Disodium

Sodium Benzoate

ANHYDROUS CITRIC ACID

SODIUM CITRATE, UNSPECIFIED FORM

Sucralose

WATER

Active Moieties

CHLORPROMAZINE