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FDA Approval

Nortriptyline Hydrochloride

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

DUNS: 832926666

Effective Date

January 8, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Nortriptyline(25 mg in 1 1)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Nortriptyline Hydrochloride

Product Details

NDC Product Code

50268-604

Application Number

ANDA075520

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 8, 2024

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

NortriptylineActive

Code: 00FN6IH15DClass: ACTIMQuantity: 25 mg in 1 1

Nortriptyline Hydrochloride

Product Details

NDC Product Code

50268-605

Application Number

ANDA075520

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 8, 2024

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

NortriptylineActive

Code: 00FN6IH15DClass: ACTIMQuantity: 50 mg in 1 1

Nortriptyline Hydrochloride

Product Details

NDC Product Code

50268-603

Application Number

ANDA075520

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 8, 2024

Ingredients

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C GREEN NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141JClass: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357Class: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQKClass: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933Class: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBDClass: IACT

NortriptylineActive

Code: 00FN6IH15DClass: ACTIMQuantity: 10 mg in 1 1

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