MedPath

NORTRIPTYLINE HYDROCHLORIDE

NORTRIPTYLINE HYDROCHLORIDE

Approved
Approval ID

bae90e1e-0b14-6e0e-e053-2a95a90af54e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 9, 2021

Manufacturers
FDA

DIRECT RX

DUNS: 079254320

Products 1

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

NORTRIPTYLINE HYDROCHLORIDE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72189-177
Application NumberANDA073556
Product Classification
M
Marketing Category
C73584
G
Generic Name
NORTRIPTYLINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 9, 2021
FDA Product Classification

INGREDIENTS (13)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42IN
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
NORTRIPTYLINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: 00FN6IH15D
Classification: ACTIM
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

NORTRIPTYLINE HYDROCHLORIDE - FDA Drug Approval Details