What is FDA product code NSC?

A pen injector is a device that provides a nonelectrically-powered, mechanically-operated method of accurately injecting a dose of medicinal product from a medicinal cartridge, reservoir, or syringe through a manually-inserted single lumen hypodermic needle. The device can be used by health professionals or for self-injection by the patient.

General Hospital › TherapeuticInjector, Pen

Genotropin Pen® 5

Name: Genotropin Pen® 5
Brand: Genotropin Pen® 5

A non-sterile, reusable pen injector designed to be used by a patient to subcutaneously inject human growth hormone using a replaceable Two-Chamber Cartridge (TCC) containing Genotropin…

Registry build 21.09.26

A non-sterile, reusable pen injector designed to be used by a patient to subcutaneously inject human growth hormone using a replaceable Two-Chamber Cartridge (TCC) containing Genotropin growth hormone inserted into the device.

2manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Zhejiang (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code NSC
Manufacturer	City	Province	Registered as	Device types
Sanmina	Kunshan	Jiangsu	Contract manufacturer	15
Promisemed Hangzhou Meditech Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	21

Record

Regulatory record for Genotropin Pen® 5
Listed by	Pharmacia & Upjohn Company LLC, United States
FDA product code	NSC
Device type	Injector, Pen
Device class	Class 2
Regulation	21 CFR 880.5860
Establishment	Manufacturer
Record published	2019-09-05
Record revised	2024-04-03 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Handling environment temperature 2 to 8 °C

Catalogue Numbers

Catalogue numbers for Genotropin Pen® 5
Catalogue number	Size	Status
F000116153		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Omnitrope Pen 10	Sandoz GmbH	2
Omnitrope® Pen 5	Sandoz GmbH	2
Follistim PEN Starter KIT	Organon LLC	1
AutoTouch Connect reusable autoinjector	Amgen, Inc.	1
Follistim PEN Starter KIT SAM USA	Merck, Sharp & Dohme	1
Follistim PEN Starter KIT USA	Merck, Sharp & Dohme	1
Follistim PEN Starter KIT SAM	Organon LLC	1
Genotropin Pen® 12	Pharmacia & Upjohn Company LLC	1
AutoTouch reusable autoinjector	Amgen, Inc.	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.