chlorpromazine hydrochloride
Chlorpromazine Hydrochloride Tablets, USP10 mg, 25 mg, 50 mg, 100 mg, and 200 mg
Approved
Approval ID
33c01749-ef88-4e9c-8b45-0f026af1d5fd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 21, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 4
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 Code53808-0924
Application NumberANDA083386
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORPROMAZINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2010
FDA Product Classification
INGREDIENTS (16)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CHLORPROMAZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CALCIUM SULFATEInactive
Code: WAT0DDB505
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
CHLORPROMAZINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0925
Application NumberANDA083386
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORPROMAZINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2010
FDA Product Classification
INGREDIENTS (16)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CHLORPROMAZINE HYDROCHLORIDEActive
Quantity: 50 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
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
CHLORPROMAZINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0931
Application NumberANDA083386
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORPROMAZINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2010
FDA Product Classification
INGREDIENTS (16)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CHLORPROMAZINE HYDROCHLORIDEActive
Quantity: 200 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
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
CHLORPROMAZINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0928
Application NumberANDA083386
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORPROMAZINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateMay 21, 2010
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 BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT