Suboxone
NDC Package 55700-147-30
Package Information
Suboxone is this medication contains 2 medicines: buprenorphine and naloxone. Marketed by Quality Care Products, Llc, this product is identified by NDC 55700-147 and is authorized under FDA application NDA022410.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 55700 - Quality Care Products, Llc
- 55700-147 - Suboxone
- 55700-147-30 - 30 FILM, SOLUBLE in 1 CARTON
- 55700-147 - Suboxone
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 55700-147-30 identifies a specific commercial package of 30 film, soluble in 1 carton of Suboxone, labeled by Quality Care Products, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 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 Quality Care Products, Llc on September 13, 2010. The current certification is valid through October 11, 2019.
What are the primary indications for this medication?
This medication contains 2 medicines: buprenorphine and naloxone. It is used to treat opioid dependence/addiction. Buprenorphine belongs to a class of drugs called mixed opioid agonist-antagonists. Buprenorphine helps prevent withdrawal symptoms caused by stopping other opioids. Naloxone is an opioid antagonist that blocks the effect of opioids and can cause severe opioid withdrawal when injected. Withdrawal is less likely when naloxone is taken by mouth, dissolved under the tongue, or dissolved on the inside of the cheek. It is combined with buprenorphine to prevent abuse and misuse (injection) of this medication. This combination medication is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).
How is this Quality Care Products, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 55700014730. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 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.