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  4. NDC Product Code: 76519-1079 Hydrocodone Bitartrate And Acetaminophen

NDC 76519-1079 Hydrocodone Bitartrate And Acetaminophen

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 76519-1079?
  5. Hydrocodone Bitartrate And Acetaminophen Uses
  6. Active Ingredients UNII Codes
  7. 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:
76519-1079
Proprietary Name:
Hydrocodone Bitartrate And Acetaminophen
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:
76ded294-0796-6c12-e053-2a91aa0a4c4c
Start Marketing Date: [9]
01-28-2016
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
OVAL (C48345)
Size(s):
6 MM
Imprint(s):
BP;649;7;5
Score:
2

Product Packages

NDC Code 76519-1079-3

Package Description: 30 TABLET in 1 BOTTLE

Product Details

What is NDC 76519-1079?

The NDC code 76519-1079 is assigned by the FDA to the product Hydrocodone Bitartrate And Acetaminophen which is product labeled by H.j. Harkins Company, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 76519-1079-3 30 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 Hydrocodone Bitartrate And Acetaminophen?

Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of Use Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [seeWARNINGS], reserve Hydrocodone Bitartrate and Acetaminophen Tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics): have not been tolerated, or are not expected to be tolerated,have not provided adequate analgesia, or are not expected to provide adequate analgesia

Which are Hydrocodone Bitartrate And Acetaminophen UNII Codes?

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

What is the NDC to RxNorm Crosswalk for Hydrocodone Bitartrate And Acetaminophen?

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:
  • RxCUI: 856987 - HYDROcodone bitartrate 5 MG / acetaminophen 300 MG Oral Tablet
  • RxCUI: 856987 - acetaminophen 300 MG / hydrocodone bitartrate 5 MG Oral Tablet
  • RxCUI: 856987 - APAP 300 MG / hydrocodone bitartrate 5 MG Oral Tablet
  • RxCUI: 856992 - HYDROcodone bitartrate 7.5 MG / acetaminophen 300 MG Oral Tablet
  • RxCUI: 856992 - acetaminophen 300 MG / hydrocodone bitartrate 7.5 MG Oral Tablet

* 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".