MedPath
FDA Product

Nortriptyline Hydrochloride

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Nortriptyline Hydrochloride

51862-018

Regulatory Information

51862-018

ANDA073556

C73584

March 24, 2021

USA

Nortriptyline Hydrochloride Capsules USP

HUMAN PRESCRIPTION DRUG LABEL

9

Company Information

Mayne Pharma Inc.

867220261

Active Ingredients

Nortriptyline Hydrochloride

Quantity: 75 mg in 1 1

Code: 00FN6IH15D

Class Code: ACTIM

Inactive Ingredients

Magnesium Stearate

Code: 70097M6I30

Class Code: IACT

Sodium Lauryl Sulfate

Code: 368GB5141J

Class Code: IACT

Propylparaben

Code: Z8IX2SC1OH

Class Code: IACT

SODIUM PROPIONATE

Code: DK6Y9P42IN

Class Code: IACT

FD&C Blue No. 1

Code: H3R47K3TBD

Class Code: IACT

D&C Yellow No. 10

Code: 35SW5USQ3G

Class Code: IACT

Silicon Dioxide

Code: ETJ7Z6XBU4

Class Code: IACT

Gelatin, Unspecified

Code: 2G86QN327L

Class Code: IACT

Methylparaben

Code: A2I8C7HI9T

Class Code: IACT

Titanium Dioxide

Code: 15FIX9V2JP

Class Code: IACT

Benzyl Alcohol

Code: LKG8494WBH

Class Code: IACT

Butylparaben

Code: 3QPI1U3FV8

Class Code: IACT

Starch, Corn

Code: O8232NY3SJ

Class Code: IACT

Edetate Calcium Disodium

Code: 25IH6R4SGF

Class Code: IACT

Active Moieties

Nortriptyline

Code: BL03SY4LXB

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