Chlorpromazine Hydrochloride
chlorproMAZINE Hydrochloride Tablets, USP
Approved
Approval ID
5ae79c1e-f523-4358-9f8b-7382a03d59bc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 5, 2023
Manufacturers
FDA
Upsher-Smith Laboratories, LLC
DUNS: 047251004
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 Code0832-6020
Application NumberANDA084114
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorpromazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2021
FDA Product Classification
INGREDIENTS (8)
Chlorpromazine HydrochlorideActive
Quantity: 100 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Chlorpromazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0832-6018
Application NumberANDA084112
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorpromazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2021
FDA Product Classification
INGREDIENTS (8)
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Chlorpromazine HydrochlorideActive
Quantity: 25 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Chlorpromazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0832-6019
Application NumberANDA084113
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorpromazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2021
FDA Product Classification
INGREDIENTS (8)
Chlorpromazine HydrochlorideActive
Quantity: 50 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Chlorpromazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0832-6017
Application NumberANDA083386
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorpromazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2021
FDA Product Classification
INGREDIENTS (8)
Chlorpromazine HydrochlorideActive
Quantity: 10 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Chlorpromazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0832-6021
Application NumberANDA084115
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorpromazine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 11, 2021
FDA Product Classification
INGREDIENTS (8)
Chlorpromazine HydrochlorideActive
Quantity: 200 mg in 1 1
Code: 9WP59609J6
Classification: ACTIB
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Lactose MonohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT