chlorpromazine hydrochloride
ChlorproMAZINE Hydrochloride Tablets, USP Rx only
Approved
Approval ID
e9d6a9e9-ba25-4c25-9b03-25897a3ac5f3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-421
Application NumberANDA212630
Product Classification
M
Marketing Category
C73584
G
Generic Name
chlorpromazine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification
INGREDIENTS (17)
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CHLORPROMAZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
chlorpromazine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-420
Application NumberANDA212630
Product Classification
M
Marketing Category
C73584
G
Generic Name
chlorpromazine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification
INGREDIENTS (17)
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CHLORPROMAZINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
chlorpromazine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-423
Application NumberANDA212630
Product Classification
M
Marketing Category
C73584
G
Generic Name
chlorpromazine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification
INGREDIENTS (17)
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CHLORPROMAZINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
chlorpromazine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-422
Application NumberANDA212630
Product Classification
M
Marketing Category
C73584
G
Generic Name
chlorpromazine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification
INGREDIENTS (17)
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
SUCROSEInactive
Code: C151H8M554
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 Code62135-424
Application NumberANDA212630
Product Classification
M
Marketing Category
C73584
G
Generic Name
chlorpromazine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification
INGREDIENTS (17)
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
CALCIUM CARBONATEInactive
Code: H0G9379FGK
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CHLORPROMAZINE HYDROCHLORIDEActive
Quantity: 200 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB