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
NDC Product Code0832-6020
Application NumberANDA084114
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 11, 2021
Generic NameChlorpromazine Hydrochloride
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
NDC Product Code0832-6018
Application NumberANDA084112
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 11, 2021
Generic NameChlorpromazine Hydrochloride
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
NDC Product Code0832-6019
Application NumberANDA084113
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 11, 2021
Generic NameChlorpromazine Hydrochloride
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
NDC Product Code0832-6017
Application NumberANDA083386
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 11, 2021
Generic NameChlorpromazine Hydrochloride
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
NDC Product Code0832-6021
Application NumberANDA084115
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateAugust 11, 2021
Generic NameChlorpromazine Hydrochloride
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