MedPath

DESIPRAMINE HYDROCHLORIDE

Desipramine Hydrochloride Tablets, USP

Approved
Approval ID

cad14805-64d8-4257-b5f1-d56e0063f0e2

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 11, 2021

Manufacturers
FDA

Alembic Pharmaceuticals Inc.

DUNS: 079288842

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 Code62332-320
Application NumberANDA209785
Product Classification
M
Marketing Category
C73584
G
Generic Name
DESIPRAMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2021
FDA Product Classification

INGREDIENTS (10)

DESIPRAMINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT

DESIPRAMINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62332-318
Application NumberANDA209785
Product Classification
M
Marketing Category
C73584
G
Generic Name
DESIPRAMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2021
FDA Product Classification

INGREDIENTS (12)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 75 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT

DESIPRAMINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62332-315
Application NumberANDA209785
Product Classification
M
Marketing Category
C73584
G
Generic Name
DESIPRAMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2021
FDA Product Classification

INGREDIENTS (12)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT

DESIPRAMINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62332-316
Application NumberANDA209785
Product Classification
M
Marketing Category
C73584
G
Generic Name
DESIPRAMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2021
FDA Product Classification

INGREDIENTS (13)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT

DESIPRAMINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62332-319
Application NumberANDA209785
Product Classification
M
Marketing Category
C73584
G
Generic Name
DESIPRAMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2021
FDA Product Classification

INGREDIENTS (13)

MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT

DESIPRAMINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code62332-317
Application NumberANDA209785
Product Classification
M
Marketing Category
C73584
G
Generic Name
DESIPRAMINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2021
FDA Product Classification

INGREDIENTS (13)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DESIPRAMINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 1Y58DO4MY1
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)Inactive
Code: UKE75GEA7F
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

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