Desipramine Hydrochloride
Desipramine Hydrochloride Tablets, USP (10 mg, 25 mg, 50 mg, 75 mg, 100 mg & 150 mg)
Approved
Approval ID
a3b4b25d-0ddb-4531-badb-f1ba3168ac07
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Desipramine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1055
Application NumberANDA208105
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desipramine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Desipramine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1063
Application NumberANDA208105
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desipramine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (9)
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Desipramine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1059
Application NumberANDA208105
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desipramine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (12)
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
Desipramine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1057
Application NumberANDA208105
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desipramine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (12)
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Desipramine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1053
Application NumberANDA208105
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desipramine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Desipramine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69238-1061
Application NumberANDA208105
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desipramine
Product Specifications
Route of AdministrationORAL
Effective DateMarch 15, 2023
FDA Product Classification
INGREDIENTS (11)
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT