Symlinpen Injection
NDC Package 0310-6627-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Symlinpen (pramlintide acetate) injection is pramlintide is used with mealtime insulin and a proper diet and exercise program to control high blood sugar in people with type 1 and type 2 diabetes. This formulation utilizes a injection delivery system. Marketed by Astrazeneca Pharmaceuticals Lp, this product is identified by NDC 0310-6627 and is authorized under FDA application NDA021332.

Identification & Billing

NDC Package Code
0310-6627-02
Package Description
2 CARTRIDGE in 1 CARTON / 2.7 mL in 1 CARTRIDGE
Product Code
0310-6627
11-Digit Billing Format
00310662702
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 861042 - pramlintide acetate 1000 MCG/ML in 2.7 ML Pen Injector
  • RxCUI: 861042 - 2.7 ML pramlintide acetate 1 MG/ML Pen Injector
  • RxCUI: 861042 - pramlintide acetate 2.7 MG per 2.7 ML Pen Injector
  • RxCUI: 861042 - pramlintide acetate 2700 MCG per 2.7 ML Pen Injector
  • RxCUI: 861043 - SymlinPen 120 1000 MCG/ML in 2.7 mL Pen Injector

Clinical Specifications

Proprietary Name
Symlinpen
Non-Proprietary Name
Pramlintide Acetate
Substance Name
Pramlintide Acetate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
PRAMLINTIDE ACETATE 1000 ug/mL
Pharmacologic Class
Usage Information
Pramlintide is used with mealtime insulin and a proper diet and exercise program to control high blood sugar in people with type 1 and type 2 diabetes. It is used when patients who are already using insulin need better blood sugar control. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Pramlintide acts like a certain natural substance called amyrin, which lowers blood sugar. This drug works by slowing the movement of food through your stomach. It also decreases your appetite and the amount of sugar your liver makes. Pramlintide does not replace insulin, but it may lower the amount of insulin you need.

Regulatory & Marketing

Labeler Name
Astrazeneca Pharmaceuticals Lp
Product Type
Human Prescription Drug
FDA Application #
NDA021332
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-08-2015
End Marketing Date
01-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0310-6627-02 identifies a specific commercial package of 2 cartridge in 1 carton / 2.7 ml in 1 cartridge of Symlinpen, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. This injection is formulated for subcutaneous use and contains pramlintide acetate as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Astrazeneca Pharmaceuticals Lp on January 08, 2015.

What are the primary indications for this medication?

Pramlintide is used with mealtime insulin and a proper diet and exercise program to control high blood sugar in people with type 1 and type 2 diabetes. It is used when patients who are already using insulin need better blood sugar control. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Pramlintide acts like a certain natural substance called amyrin, which lowers blood sugar. This drug works by slowing the movement of food through your stomach. It also decreases your appetite and the amount of sugar your liver makes. Pramlintide does not replace insulin, but it may lower the amount of insulin you need.

How is this Astrazeneca Pharmaceuticals Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00310662702. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0310-6627-02
11-Digit CMS (5-4-2)
00310-6627-02

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.