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Chlorpromazine Hydrochloride

Chlorpromazine Hydrochloride Tablets, USP 10 mg, 25 mg, 50 mg, 100 mg, and 200 mg

Approved
Approval ID

f2f6ab54-5bab-4fa7-a7ac-0ec3bbc75bfd

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 25, 2011

Manufacturers
FDA

Carilion Materials Management

DUNS: 079239644

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Chlorpromazine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68151-2478
Application NumberANDA084112
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorpromazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 25, 2011
FDA Product Classification

INGREDIENTS (18)

Chlorpromazine HydrochlorideActive
Quantity: 25 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
Ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
AcaciaInactive
Code: 5C5403N26O
Classification: IACT
Calcium SulfateInactive
Code: WAT0DDB505
Classification: IACT
Carnauba WaxInactive
Code: R12CBM0EIZ
Classification: IACT
D&C Yellow NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C Yellow NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
FD&C Blue NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
PropylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
POVIDONESInactive
Code: FZ989GH94E
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Sodium BenzoateInactive
Code: OJ245FE5EU
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT

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Chlorpromazine Hydrochloride - FDA Drug Approval Details