Chlorpromazine Hydrochloride
chlorproMAZINE Hydrochloride Tablets, USP
Approved
Approval ID
1049538a-c012-41bf-932e-3c85f57f9577
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 19, 2020
Manufacturers
FDA
Lannett Company, Inc.
DUNS: 002277481
Products 5
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 Code0527-2963
Application NumberANDA212996
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorpromazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2020
FDA Product Classification
INGREDIENTS (12)
D&C Yellow NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C Blue NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C Yellow NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10N
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Chlorpromazine HydrochlorideActive
Quantity: 50 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
Chlorpromazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-2965
Application NumberANDA212996
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorpromazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2020
FDA Product Classification
INGREDIENTS (12)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C Yellow NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Chlorpromazine HydrochlorideActive
Quantity: 200 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
D&C Yellow NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C Blue NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10N
Classification: IACT
Chlorpromazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-2962
Application NumberANDA212996
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorpromazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2020
FDA Product Classification
INGREDIENTS (12)
Chlorpromazine HydrochlorideActive
Quantity: 25 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
D&C Yellow NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C Blue NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C Yellow NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10N
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Chlorpromazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-2964
Application NumberANDA212996
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorpromazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2020
FDA Product Classification
INGREDIENTS (12)
Chlorpromazine HydrochlorideActive
Quantity: 100 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
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
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10N
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Chlorpromazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-2961
Application NumberANDA212996
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorpromazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2020
FDA Product Classification
INGREDIENTS (12)
Chlorpromazine HydrochlorideActive
Quantity: 10 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
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
GLYCERYL MONOCAPRYLOCAPRATEInactive
Code: G7515SW10N
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT