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  4. NDC Product Code: 76519-1081 Hydrocodone Bitartrate And Acetaminophen

NDC 76519-1081 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 76519-1081?
  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.

Get all the details for National Drug Code (NDC) 76519-1081 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
76519-1081
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
FDA Application Number: [6]
ANDA090415
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date: [9]
01-28-2016
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
OVAL (C48345)
Size(s):
6 MM
Imprint(s):
BP;649;7;5
BP;648;5
Score:
2

Code Structure Chart

Product Details

What is NDC 76519-1081?

The NDC code 76519-1081 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 3 packages with assigned NDC codes 76519-1081-1 10 tablet in 1 bottle , 76519-1081-3 30 tablet in 1 bottle , 76519-1081-4 4 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.

[6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

[8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".