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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

Taro Pharmaceuticals U.S.A., Inc.

DUNS: 145186370

Effective Date

May 4, 2020

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Nortriptyline(10 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Taro Pharmaceutical Industries, Ltd.

Labeler

Taro Pharmaceuticals U.S.A., Inc.

DUNS Number

600072078

Products4

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

51672-4001

Application Number

ANDA075520

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 4, 2020

Ingredients

starch, cornInactive

Code: O8232NY3SJClass: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

NortriptylineActive

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

magnesium stearateInactive

Code: 70097M6I30Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

sodium lauryl sulfateInactive

Code: 368GB5141JClass: IACT

D&C Yellow NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C Green NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

shellacInactive

Code: 46N107B71OClass: 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

ferrosoferric oxideInactive

Code: XM0M87F357Class: IACT

Nortriptyline Hydrochloride

Product Details

NDC Product Code

51672-4003

Application Number

ANDA075520

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 4, 2020

Ingredients

starch, cornInactive

Code: O8232NY3SJClass: IACT

D&C Yellow NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

NortriptylineActive

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

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

FD&C Green NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

sodium lauryl sulfateInactive

Code: 368GB5141JClass: IACT

shellacInactive

Code: 46N107B71OClass: IACT

ferrosoferric oxideInactive

Code: XM0M87F357Class: IACT

FD&C Blue NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FD&C Red NO. 40Inactive

Code: WZB9127XOAClass: IACT

FD&C Blue NO. 1Inactive

Code: H3R47K3TBDClass: IACT

Nortriptyline Hydrochloride

Product Details

NDC Product Code

51672-4004

Application Number

ANDA075520

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 4, 2020

Ingredients

NortriptylineActive

Code: 00FN6IH15DClass: ACTIMQuantity: 75 mg in 1 1

starch, cornInactive

Code: O8232NY3SJClass: IACT

magnesium stearateInactive

Code: 70097M6I30Class: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

D&C Yellow NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

FD&C Blue NO. 2Inactive

Code: L06K8R7DQKClass: IACT

FD&C Green NO. 3Inactive

Code: 3P3ONR6O1SClass: IACT

ferrosoferric oxideInactive

Code: XM0M87F357Class: IACT

shellacInactive

Code: 46N107B71OClass: IACT

sodium lauryl sulfateInactive

Code: 368GB5141JClass: IACT

FD&C Blue NO. 1Inactive

Code: H3R47K3TBDClass: IACT

FD&C Red NO. 40Inactive

Code: WZB9127XOAClass: IACT

Nortriptyline Hydrochloride

Product Details

NDC Product Code

51672-4002

Application Number

ANDA075520

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

May 4, 2020

Ingredients

magnesium stearateInactive

Code: 70097M6I30Class: IACT

NortriptylineActive

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

starch, cornInactive

Code: O8232NY3SJClass: IACT

silicon dioxideInactive

Code: ETJ7Z6XBU4Class: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327LClass: IACT

titanium dioxideInactive

Code: 15FIX9V2JPClass: IACT

D&C Yellow NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

shellacInactive

Code: 46N107B71OClass: IACT

ferrosoferric oxideInactive

Code: XM0M87F357Class: IACT

FD&C Blue NO. 2Inactive

Code: L06K8R7DQKClass: IACT

sodium lauryl sulfateInactive

Code: 368GB5141JClass: IACT

FD&C Red NO. 40Inactive

Code: WZB9127XOAClass: IACT

aluminum oxideInactive

Code: LMI26O6933Class: IACT

FD&C Blue NO. 1Inactive

Code: H3R47K3TBDClass: IACT

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