Octreotide Acetate
NDC Package 64679-635-01
Package Information
Octreotide Acetate 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. Marketed by Wockhardt Usa Llc., this product is identified by NDC 64679-635 and is authorized under FDA application ANDA090985.
Identification & Billing
- RxCUI: 312068 - octreotide 50 MCG in 1 ML Injection
- RxCUI: 312068 - 1 ML octreotide 0.05 MG/ML Injection
- RxCUI: 312068 - octreotide 50 MCG per 1 ML Injection
- RxCUI: 312069 - octreotide 100 MCG in 1 ML Injection
- RxCUI: 312069 - 1 ML octreotide 0.1 MG/ML Injection
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 64679 - Wockhardt Usa Llc.
- 64679-635 - Octreotide Acetate
- 64679-635-01 - 1 VIAL in 1 CARTON / 1 mL in 1 VIAL
- 64679-635 - Octreotide Acetate
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 (64679-635). Click a package code to view its specific billing and regulatory data.
* 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 64679-635-01 identifies a specific commercial package of 1 vial in 1 carton / 1 ml in 1 vial of Octreotide Acetate, labeled by Wockhardt Usa Llc.. 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 Wockhardt Usa Llc. on May 11, 2011. The current certification is valid through December 31, 2018.
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 Wockhardt Usa Llc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 64679063501. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
