Octreotide Acetate
NDC Package 76135-011-01

11-digit billing NDC: 76135001101
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Octreotide Acetate is acromegalyOctreotide acetate injection is indicated to reduce blood levels of growth hormone and IGF-I (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. Marketed by Usv North America Inc., this product is identified by NDC 76135-011 and is authorized under FDA application ANDA204669.

Identification & Billing

NDC Package Code
76135-011-01
Package Description
10 VIAL in 1 BOX / 1 mL in 1 VIAL
Product Code
76135-011
11-Digit Billing Format
76135001101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Octreotide Acetate
Dosage Form
-
Usage Information
AcromegalyOctreotide acetate injection is indicated to reduce blood levels of growth hormone and IGF-I (somatomedin C) in acromegaly patients who have had inadequate response to or cannot be treated with surgical resection, pituitary irradiation, and bromocriptine mesylate at maximally tolerated doses. The goal is to achieve normalization of growth hormone and IGF-I (somatomedin C) levels (see DOSAGE AND ADMINISTRATION). In patients with acromegaly, octreotide acetate injection reduces growth hormone to within normal ranges in 50% of patients and reduces IGF-I (somatomedin C) to within normal ranges in 50% to 60% of patients. Since the effects of pituitary irradiation may not become maximal for several years, adjunctive therapy with octreotide acetate injection to reduce blood levels of growth hormone and IGF-I (somatomedin C) offers potential benefit before the effects of irradiation are manifested. Improvement in clinical signs and symptoms or reduction in tumor size or rate of growth were not shown in clinical trials performed with octreotide acetate injection; these trials were not optimally designed to detect such effects.Carcinoid TumorsOctreotide acetate injection is indicated for the symptomatic treatment of patients with metastatic carcinoid tumors where it suppresses or inhibits the severe diarrhea and flushing episodes associated with the disease.Octreotide acetate injection studies were not designed to show an effect on the size, rate of growth or development of metastases.Vasoactive Intestinal Peptide Tumors (VIPomas)Octreotide acetate injection is indicated for the treatment of the profuse watery diarrhea associated with VIP-secreting tumors. Octreotide acetate injection studies were not designed to show an effect on the size, rate of growth or development of metastases.

Regulatory & Marketing

Labeler Name
Usv North America Inc.
FDA Application #
ANDA204669
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-01-2019
Listing Expiration
12-31-2020
Exclude Flag
I
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 76135-011-01 identifies a specific commercial package of 10 vial in 1 box / 1 ml in 1 vial of Octreotide Acetate, labeled by Usv North America Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Usv North America Inc. on February 01, 2019. The current certification is valid through December 31, 2020.

How is this Usv North America Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76135001101. 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)
76135-011-01
11-Digit CMS (5-4-2)
76135-0011-01

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