1. Home
  2. Labeler Index
  3. H.j. Harkins Company, Inc.
  4. NDC Product Code: 76519-1170 Buprenorphine Hcl SL

NDC 76519-1170 Buprenorphine Hcl SL

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 76519-1170?
  5. Buprenorphine Hcl SL Uses
  6. Active Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
76519-1170
Proprietary Name:
Buprenorphine Hcl SL
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
H.j. Harkins Company, Inc.
Labeler Code:
76519
Product Label ID:
77d3c308-58b8-2ab0-e053-2991aa0a4918
Start Marketing Date: [9]
03-16-2018
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
10 MM
Imprint(s):
54;411
Score:
1

Code Structure Chart

Product Details

What is NDC 76519-1170?

The NDC code 76519-1170 is assigned by the FDA to the product Buprenorphine Hcl SL which is product labeled by H.j. Harkins Company, Inc.. The product's dosage form is . The product is distributed in 6 packages with assigned NDC codes 76519-1170-0 14 tablet in 1 bottle , 76519-1170-1 28 tablet in 1 bottle , 76519-1170-2 56 tablet in 1 bottle , 76519-1170-3 70 tablet in 1 bottle , 76519-1170-4 84 tablet in 1 bottle , 76519-1170-5 42 tablet in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Buprenorphine Hcl SL?

Buprenorphine is used to treat dependence/addiction to opioids. Buprenorphine belongs to a class of drugs called mixed opioid agonist-antagonists. It helps prevent withdrawal symptoms caused by stopping other opioids. It is used as part of a complete treatment program for drug abuse (such as compliance monitoring, counseling, behavioral contract, lifestyle changes).

Which are Buprenorphine Hcl SL UNII Codes?

The UNII codes for the active ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Buprenorphine Hcl SL?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

* Please review the disclaimer below.

Patient Education

Buprenorphine Sublingual and Buccal (opioid dependence)


Buprenorphine and the combination of buprenorphine and naloxone are used to treat opioid dependence (addiction to opioid drugs, including heroin and narcotic painkillers). Buprenorphine is in a class of medications called opioid partial agonist-antagonists and naloxone is in a class of medications called opioid antagonists. Buprenorphine alone and the combination of buprenorphine and naloxone work to prevent withdrawal symptoms when someone stops taking opioid drugs by producing similar effects to these drugs.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".