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chlorpromazine hydrochloride

Chlorpromazine Hydrochloride Tablets, USP50 mg and 100 mg

Approved
Approval ID

533f3ed8-4569-48e2-95ee-efe428896b8d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 25, 2010

Manufacturers
FDA

Contract Pharmacy Services-PA

DUNS: 945429777

Products 2

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 Code67046-104
Application NumberANDA084114
Product Classification
M
Marketing Category
C73584
G
Generic Name
chlorpromazine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 28, 2008
FDA Product Classification

INGREDIENTS (16)

chlorpromazine hydrochlorideActive
Quantity: 100 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
acaciaInactive
Code: 5C5403N26O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
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
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
sodium benzoateInactive
Code: OJ245FE5EU
Classification: IACT
sucroseInactive
Code: C151H8M554
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT

chlorpromazine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code67046-103
Application NumberANDA084113
Product Classification
M
Marketing Category
C73584
G
Generic Name
chlorpromazine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 28, 2008
FDA Product Classification

INGREDIENTS (16)

acaciaInactive
Code: 5C5403N26O
Classification: IACT
chlorpromazine hydrochlorideActive
Quantity: 50 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
carnauba waxInactive
Code: R12CBM0EIZ
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
calcium sulfateInactive
Code: WAT0DDB505
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
anhydrous lactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
povidoneInactive
Code: FZ989GH94E
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