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  4. NDC Product Code: 67046-997 Buprenorphine Hydrochloride Sublingual

NDC 67046-997 Buprenorphine Hydrochloride Sublingual

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 67046-997?
  5. Buprenorphine Hydrochloride Sublingual Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
67046-997
Proprietary Name:
Buprenorphine Hydrochloride Sublingual
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Contract Pharmacy Services-pa
Labeler Code:
67046
Product Label ID:
593c2a50-de4f-6bf8-e053-2a91aa0ae306
Start Marketing Date: [9]
03-06-2015
Listing Expiration Date: [11]
12-31-2021
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
6 MM
10 MM
Imprint(s):
M;923
M;924
Score:
1

Product Packages

NDC Code 67046-997-30

Package Description: 30 TABLET in 1 BLISTER PACK

Product Details

What is NDC 67046-997?

The NDC code 67046-997 is assigned by the FDA to the product Buprenorphine Hydrochloride Sublingual which is product labeled by Contract Pharmacy Services-pa. The product's dosage form is . The product is distributed in a single package with assigned NDC code 67046-997-30 30 tablet in 1 blister pack . 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 Hydrochloride Sublingual?

Buprenorphine hydrochloride sublingual tablets are indicated for the treatment of opioid dependence and are preferred for induction. Buprenorphine hydrochloride sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Under the Drug Addiction Treatment Act (DATA) codified at 21 U.S.C. 823(g), prescription use of this product in the treatment of opioid dependence is limited to healthcare providers who meet certain qualifying requirements, and who have notified the Secretary of Health and Human Services (HHS) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription.

Which are Buprenorphine Hydrochloride Sublingual UNII Codes?

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

Which are Buprenorphine Hydrochloride Sublingual Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Buprenorphine Hydrochloride Sublingual?

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:

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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".