Norpramin

Approved

Approval ID

70b562ea-9f21-4e4a-b3ed-0590b2892f6a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 12, 2023

Manufacturers

FDA

Validus Pharmaceuticals LLC

DUNS: 801194619

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 Code30698-011

Application NumberNDA014399

Product Classification

Marketing Category

C73594

Generic Name

desipramine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 8, 2023

FDA Product Classification

INGREDIENTS (15)

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

D&C RED NO. 30Inactive

Code: 2S42T2808B

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

LIGHT MINERAL OILInactive

Code: N6K5787QVP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

DESIPRAMINE HYDROCHLORIDEActive

Quantity: 25 mg in 1 1

Code: 1Y58DO4MY1

Classification: ACTIB

ACACIAInactive

Code: 5C5403N26O

Classification: IACT

desipramine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code30698-019

Application NumberNDA014399

Product Classification

Marketing Category

C73594

Generic Name

desipramine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 8, 2023

FDA Product Classification

INGREDIENTS (15)

ACACIAInactive

Code: 5C5403N26O

Classification: IACT

DESIPRAMINE HYDROCHLORIDEActive

Quantity: 75 mg in 1 1

Code: 1Y58DO4MY1

Classification: ACTIB

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

D&C RED NO. 30Inactive

Code: 2S42T2808B

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

LIGHT MINERAL OILInactive

Code: N6K5787QVP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

desipramine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code30698-021

Application NumberNDA014399

Product Classification

Marketing Category

C73594

Generic Name

desipramine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 8, 2023

FDA Product Classification

INGREDIENTS (14)

DESIPRAMINE HYDROCHLORIDEActive

Quantity: 150 mg in 1 1

Code: 1Y58DO4MY1

Classification: ACTIB

ACACIAInactive

Code: 5C5403N26O

Classification: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

D&C RED NO. 30Inactive

Code: 2S42T2808B

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

LIGHT MINERAL OILInactive

Code: N6K5787QVP

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

desipramine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code30698-007

Application NumberNDA014399

Product Classification

Marketing Category

C73594

Generic Name

desipramine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 8, 2023

FDA Product Classification

INGREDIENTS (15)

DESIPRAMINE HYDROCHLORIDEActive

Quantity: 10 mg in 1 1

Code: 1Y58DO4MY1

Classification: ACTIB

ACACIAInactive

Code: 5C5403N26O

Classification: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

D&C RED NO. 30Inactive

Code: 2S42T2808B

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

LIGHT MINERAL OILInactive

Code: N6K5787QVP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

desipramine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code30698-020

Application NumberNDA014399

Product Classification

Marketing Category

C73594

Generic Name

desipramine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 8, 2023

FDA Product Classification

INGREDIENTS (15)

DESIPRAMINE HYDROCHLORIDEActive

Quantity: 100 mg in 1 1

Code: 1Y58DO4MY1

Classification: ACTIB

ACACIAInactive

Code: 5C5403N26O

Classification: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

D&C RED NO. 30Inactive

Code: 2S42T2808B

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

LIGHT MINERAL OILInactive

Code: N6K5787QVP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

desipramine hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code30698-015

Application NumberNDA014399

Product Classification

Marketing Category

C73594

Generic Name

desipramine hydrochloride

Product Specifications

Route of AdministrationORAL

Effective DateDecember 8, 2023

FDA Product Classification

INGREDIENTS (16)

DESIPRAMINE HYDROCHLORIDEActive

Quantity: 50 mg in 1 1

Code: 1Y58DO4MY1

Classification: ACTIB

ACACIAInactive

Code: 5C5403N26O

Classification: IACT

CALCIUM CARBONATEInactive

Code: H0G9379FGK

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

D&C RED NO. 30Inactive

Code: 2S42T2808B

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

LIGHT MINERAL OILInactive

Code: N6K5787QVP

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3B

Classification: IACT

SODIUM BENZOATEInactive

Code: OJ245FE5EU

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

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Norpramin

Products 6

desipramine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

desipramine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

desipramine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (14)

desipramine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

desipramine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

desipramine hydrochloride

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

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