Butrans
NDC Package 35356-607-04
Package Information
Butrans is a medication used to help relieve severe ongoing pain (such as due to arthritis, chronic back pain). Marketed by Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc, this product is identified by NDC 35356-607 and is authorized under FDA application NDA021306.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 35356 - Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc
- 35356-607 - Butrans
- 35356-607-04 - 4 POUCH in 1 CARTON / 1 PATCH in 1 POUCH / 168 h in 1 PATCH
- 35356-607 - Butrans
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 35356-607-04 identifies a specific commercial package of 4 pouch in 1 carton / 1 patch in 1 pouch / 168 h in 1 patch of Butrans, labeled by Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. 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 Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc on March 26, 2012. The current certification is valid through June 01, 2017.
What are the primary indications for this medication?
This medication is used to help relieve severe ongoing pain (such as due to arthritis, chronic back pain). Buprenorphine belongs to a class of drugs known as opioid analgesics. It works in the brain to change how your body feels and responds to pain. The higher strengths of this drug (7.5, 10, 15, or 20 micrograms per hour patches) should be used only if you have been regularly taking moderate amounts of opioid pain medication. These strengths may cause overdose (even death) if used by a person who has not been regularly taking opioids. Do not use this medication to relieve pain that is mild or that will go away in a few days. This medication is not for occasional ("as needed") use.
How is this Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 35356060704. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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.