Desipramine Hydrochloride
Desipramine Hydrochloride Tablets, USP
Approved
Approval ID
3bada7cf-8ca2-46e9-b7db-ff21b2af03f7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 21, 2016
Manufacturers
FDA
INDICUS PHARMA LLC
DUNS: 793870606
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 Code24724-071
Application NumberANDA207433
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desipramine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2016
FDA Product Classification
INGREDIENTS (9)
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
Desipramine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24724-070
Application NumberANDA207433
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desipramine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2016
FDA Product Classification
INGREDIENTS (9)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
Desipramine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24724-072
Application NumberANDA207433
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desipramine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2016
FDA Product Classification
INGREDIENTS (9)
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Desipramine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24724-068
Application NumberANDA207433
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desipramine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2016
FDA Product Classification
INGREDIENTS (9)
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
Desipramine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24724-067
Application NumberANDA207433
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desipramine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2016
FDA Product Classification
INGREDIENTS (9)
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Desipramine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24724-069
Application NumberANDA207433
Product Classification
M
Marketing Category
C73584
G
Generic Name
Desipramine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJuly 21, 2016
FDA Product Classification
INGREDIENTS (9)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT