DESIPRAMINE HYDROCHLORIDE
Desipramine Hydrochloride Tablets, USP
Approved
Approval ID
7280f157-3fff-41c5-b3f4-510b8bacdaba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 22, 2023
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
Products 6
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
desipramine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-113
Application NumberANDA204963
Product Classification
M
Marketing Category
C73584
G
Generic Name
desipramine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 22, 2023
FDA Product Classification
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
desipramine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-115
Application NumberANDA204963
Product Classification
M
Marketing Category
C73584
G
Generic Name
desipramine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 22, 2023
FDA Product Classification
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
desipramine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-116
Application NumberANDA204963
Product Classification
M
Marketing Category
C73584
G
Generic Name
desipramine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 22, 2023
FDA Product Classification
INGREDIENTS (8)
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
desipramine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-112
Application NumberANDA204963
Product Classification
M
Marketing Category
C73584
G
Generic Name
desipramine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 22, 2023
FDA Product Classification
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
desipramine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-117
Application NumberANDA204963
Product Classification
M
Marketing Category
C73584
G
Generic Name
desipramine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 22, 2023
FDA Product Classification
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
desipramine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-114
Application NumberANDA204963
Product Classification
M
Marketing Category
C73584
G
Generic Name
desipramine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJune 22, 2023
FDA Product Classification
INGREDIENTS (8)
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT