Nortriptyline HCL

Approved

Approval ID

8024d787-333d-1235-e053-2991aa0a7e4c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 11, 2019

Manufacturers

FDA

Direct_Rx

DUNS: 079254320

Products 2

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

NORTRIPTYLINE HCI

Product Details

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code61919-285

Application NumberANDA075520

Product Classification

Marketing Category

C73584

Generic Name

NORTRIPTYLINE HCI

Product Specifications

Route of AdministrationORAL

Effective DateMarch 11, 2019

FDA Product Classification

INGREDIENTS (14)

NORTRIPTYLINE HYDROCHLORIDEActive

Quantity: 25 mg in 1 1

Code: 00FN6IH15D

Classification: ACTIM

GELATINInactive

Code: 2G86QN327L

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

FD&C RED NO. 40Inactive

Code: WZB9127XOA

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

ALUMINUM OXIDEInactive

Code: LMI26O6933

Classification: IACT

FD&C BLUE NO. 1Inactive

Code: H3R47K3TBD

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3G

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT