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

Omnitrope Pen 10

Name: Omnitrope Pen 10
Brand: Omnitrope Pen 10

The Omnitrope Pen 10 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It…

Registry build 21.09.26

The Omnitrope Pen 10 is a reusable injection pen for use with Omnitrope cartridges. Omnitrope Pen from BD is intended for subcutaneous injection of a daily dose of Omnitrope (rhGH drug). It is intended for patients (pediatric patients and adults) treated for growth disturbances and growth hormone deficiencies. The injection can be performed by the patient him/herself or also by a trained caregiver in case of small children or patients unable to perform the injection themselves. For information on the use of Omnitrope Pen 10, see:

2manufacturers in China registered for this device type

2catalogue numbers in this listing

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 Omnitrope Pen 10
Listed by	Sandoz GmbH
FDA product code	NSC
Device type	Injector, Pen
Device class	Class 2
Regulation	21 CFR 880.5860
Record published	2023-02-07
Record revised	2025-05-09 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number
Distribution end date	2024-11-13

Catalogue Numbers

Catalogue numbers for Omnitrope Pen 10
Catalogue number	Size	Status
49041459		In distribution
49041459		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
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
Genotropin Pen® 5	Pharmacia & Upjohn Company LLC	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.