Chlorpromazine Hydrochloride
ChlorproMAZINE Hydrochloride Tablets, USP
Approved
Approval ID
fd9d3297-b324-4472-8cab-5f322b5271c9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 6, 2018
Manufacturers
FDA
Carilion Materials Management
DUNS: 079239644
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 Code68151-2480
Application NumberANDA083386
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorpromazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2017
FDA Product Classification
INGREDIENTS (18)
CHLORPROMAZINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
AcaciaInactive
Code: 5C5403N26O
Classification: IACT
Ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
Calcium Sulfate, Unspecified formInactive
Code: WAT0DDB505
Classification: IACT
D&C Yellow NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C Yellow NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
FD&C Blue NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Carnauba WaxInactive
Code: R12CBM0EIZ
Classification: IACT
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
Povidone, UnspecifiedInactive
Code: FZ989GH94E
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Sodium BenzoateInactive
Code: OJ245FE5EU
Classification: IACT
PropylparabenInactive
Code: Z8IX2SC1OH
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 Code68151-2479
Application NumberANDA084113
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorpromazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2017
FDA Product Classification
INGREDIENTS (18)
AcaciaInactive
Code: 5C5403N26O
Classification: IACT
CHLORPROMAZINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
Calcium Sulfate, Unspecified formInactive
Code: WAT0DDB505
Classification: IACT
Aluminum OxideInactive
Code: LMI26O6933
Classification: IACT
D&C Yellow NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Ferrosoferric oxideInactive
Code: XM0M87F357
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
Anhydrous LactoseInactive
Code: 3SY5LH9PMK
Classification: IACT
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
Povidone, UnspecifiedInactive
Code: FZ989GH94E
Classification: IACT
PropylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Sodium BenzoateInactive
Code: OJ245FE5EU
Classification: IACT
SucroseInactive
Code: C151H8M554
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 9/13/2017
Rx only
Manufactured by
UPSHER-SMITH LABORATORIES, LLC
Maple Grove, MN 55369
Revised 0817