NDC 10702-345 Benzhydrocodone And Acetaminophen

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
10702-345
Proprietary Name:
Benzhydrocodone And Acetaminophen
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Kvk-tech, Inc.
Labeler Code:
10702
Start Marketing Date: [9]
06-28-2019
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
15 MM
Imprint(s):
KP201;890
Score:
1

Product Packages

NDC Code 10702-345-01

Package Description: 100 TABLET in 1 BOTTLE, PLASTIC

Product Details

What is NDC 10702-345?

The NDC code 10702-345 is assigned by the FDA to the product Benzhydrocodone And Acetaminophen which is product labeled by Kvk-tech, Inc.. The product's dosage form is . The product is distributed in a single package with assigned NDC code 10702-345-01 100 tablet in 1 bottle, plastic . 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 Benzhydrocodone And Acetaminophen?

Benzhydrocodone and Acetaminophen tablets are indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.Limitations of UseBecause of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)], reserve Benzhydrocodone 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 Benzhydrocodone And Acetaminophen UNII Codes?

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

Which are Benzhydrocodone And Acetaminophen 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 Benzhydrocodone 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: 2001358 - benzyhydrocodone 6.12 MG / acetaminophen 325 MG Oral Tablet
  • RxCUI: 2001358 - acetaminophen 325 MG / benzhydrocodone 6.12 MG Oral Tablet
  • RxCUI: 2001358 - acetaminophen 325 MG / benzhydrocodone 6.12 MG (as benzhydrocodone HCl 6.67 MG) Oral Tablet
  • RxCUI: 2001358 - APAP 325 MG / benzhydrocodone 6.12 MG Oral Tablet
  • RxCUI: 2118728 - benzhydrocodone 4.08 MG / acetaminophen 325 MG Oral Tablet

* Please review the disclaimer below.

Patient Education

Benzhydrocodone and Acetaminophen


The combination of benzhydrocodone and acetaminophen is used to relieve acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed) that cannot be relieved by other non-opioid pain medications. Benzhydrocodone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). When acetaminophen is used in combination with benzhydrocodone to treat pain, it works by changing the way the body senses pain.
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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".