NDC Package 55390-163-01 Octreotide Acetate

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Package Information
Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory .

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:

55390-163-01

Package Description:

1 VIAL in 1 BOX / 5 mL in 1 VIAL

Product Code:

55390-163

Proprietary Name:

Octreotide Acetate

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).

11-Digit NDC Billing Format:

55390016301

Billing Unit:

ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Labeler Name:

Bedford Laboratories

Sample Package:

FDA Application Number:

ANDA076330

Marketing Category:

ANDA - A product marketed under an approved Abbreviated New Drug Application.

Start Marketing Date:

04-08-2005

End Marketing Date:

12-31-2014

Listing Expiration Date:

12-31-2014

Exclude Flag:

Code Structure:

55390 - Bedford Laboratories
- 55390-163 - Octreotide Acetate
  - 55390-163-01 - 1 VIAL in 1 BOX / 5 mL in 1 VIAL

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 disclaimer below.

Frequently Asked Questions

What is NDC 55390-163-01?

The NDC Packaged Code 55390-163-01 is assigned to a package of 1 vial in 1 box / 5 ml in 1 vial of Octreotide Acetate, labeled by Bedford Laboratories. The product's dosage form is and is administered via form.

Is NDC 55390-163 included in the NDC Directory?

The product was first marketed by Bedford Laboratories on April 08, 2005 and its listing in the NDC Directory is set to expire on December 31, 2014 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 55390-163-01?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 55390-163-01?

The 11-digit format is 55390016301. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format	10-Digit Original Code	11-Digit Format	11-Digit Code
5-3-2	55390-163-01	5-4-2	55390-0163-01

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