Bynfezia Pen Injection
NDC Package 62756-452-37

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

Package Information

Bynfezia Pen (octreotide acetate) injection is octreotide is used to treat severe watery diarrhea and sudden reddening of the face and neck caused by certain types of tumors (such as carcinoid tumors, vasoactive intestinal peptide tumors) that are found usually in the intestines and pancreas. This formulation utilizes a injection delivery system. Marketed by Sun Pharmaceutical Industries, Inc., this product is identified by NDC 62756-452 and is authorized under FDA application NDA213224.

Identification & Billing

NDC Package Code
62756-452-37
Package Description
2 CARTRIDGE in 1 CARTON / 2.8 mL in 1 CARTRIDGE
Product Code
62756-452
11-Digit Billing Format
62756045237
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2360543 - octreotide 2500 MCG/ML in 2.8 ML Pen Injector
  • RxCUI: 2360543 - 2.8 ML octreotide 2.5 MG/ML Pen Injector
  • RxCUI: 2360543 - octreotide (as octreotide acetate) 2.5 MG/ML per 2.8 ML Pen Injector
  • RxCUI: 2360543 - octreotide (as octreotide acetate) 2500 MCG/ML per 2.8 ML Pen Injector
  • RxCUI: 2360543 - octreotide (as octreotide acetate) 7000 MCG per 2.8 ML Pen Injector

Clinical Specifications

Proprietary Name
Bynfezia Pen
Non-Proprietary Name
Octreotide Acetate
Substance Name
Octreotide 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)
OCTREOTIDE ACETATE 2.5 mg/mL
Pharmacologic Class
Usage Information
Octreotide is used to treat severe watery diarrhea and sudden reddening of the face and neck caused by certain types of tumors (such as carcinoid tumors, vasoactive intestinal peptide tumors) that are found usually in the intestines and pancreas. The symptoms occur when these tumors make too much of certain natural substances (hormones). This medication works by blocking the production of these hormones. By decreasing watery diarrhea, octreotide helps to reduce the loss of body fluids and minerals. Octreotide is also used to treat a certain condition (acromegaly) that occurs when the body makes too much of a certain natural substance called growth hormone. Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease. Octreotide works by decreasing the amount of growth hormone to normal levels. This drug is not a cure for these conditions. This medication is usually used with other treatment (such as surgery, radiation, other drugs).

Regulatory & Marketing

Labeler Name
Sun Pharmaceutical Industries, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA213224
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-24-2025
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (62756-452). Click a package code to view its specific billing and regulatory data.

62756-452-36
1 CARTRIDGE in 1 CARTON / 2.8 mL in 1 CARTRIDGE

* 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 62756-452-37 identifies a specific commercial package of 2 cartridge in 1 carton / 2.8 ml in 1 cartridge of Bynfezia Pen, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. This injection is formulated for subcutaneous use and contains octreotide 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 Sun Pharmaceutical Industries, Inc. on February 24, 2025. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Octreotide is used to treat severe watery diarrhea and sudden reddening of the face and neck caused by certain types of tumors (such as carcinoid tumors, vasoactive intestinal peptide tumors) that are found usually in the intestines and pancreas. The symptoms occur when these tumors make too much of certain natural substances (hormones). This medication works by blocking the production of these hormones. By decreasing watery diarrhea, octreotide helps to reduce the loss of body fluids and minerals. Octreotide is also used to treat a certain condition (acromegaly) that occurs when the body makes too much of a certain natural substance called growth hormone. Treating acromegaly helps reduce the risk of serious problems such as diabetes and heart disease. Octreotide works by decreasing the amount of growth hormone to normal levels. This drug is not a cure for these conditions. This medication is usually used with other treatment (such as surgery, radiation, other drugs).

How is this Sun Pharmaceutical Industries, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62756045237. 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 (5-3-2)
62756-452-37
11-Digit CMS (5-4-2)
62756-0452-37

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