Apadaz Tablet
NDC 70040-0189
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
Apadaz (benzhydrocodone and acetaminophen) is a NDA-approved product labeled by Zevra Therapeutics, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a white tablet for oral administration. This product entry covers the primary NDC 70040-0189 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
70040-0189
Proprietary Name:
Apadaz
Non-Proprietary Name: [1]
Benzhydrocodone And Acetaminophen
Substance Name: [2]
Acetaminophen; Benzhydrocodone Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:
Clinical Specifications
Dosage Form:
Tablet
- A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
70040
Product Label ID:
FDA Application Number: [6]
NDA208653
DEA Schedule: [7]
Schedule II (CII) Substances
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Marketing Timeline
Start Marketing Date: [9]
02-23-2018
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Product Characteristics
Color(s):
WHITE (C48325)
Shape:
CAPSULE (C48336)
Size(s):
15 MM
Imprint(s):
KP201
KP201;445
KP201;890
Score:
1
Code Structure Chart
Product Details
What is NDC 70040-0189?
The NDC code 70040-0189 is assigned by the FDA to the product Apadaz. It is commonly known by its generic name, benzhydrocodone and acetaminophen. This pharmaceutical product is labeled by Zevra Therapeutics, Inc. and is currently categorized as listed product. The medication is a tablet administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 70040-0189-1. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.
What are the uses of this product?
APADAZ is contraindicated in patients with:Significant respiratory depression [see Warnings and Precautions (5.3)]Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8)]Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.14)]Hypersensitivity to hydrocodone or acetaminophen, or any other component of this product (e.g., anaphylaxis) [see Warnings and Precautions (5.13), Adverse Reactions (6)]
What are Active Ingredients of this product?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
- ACETAMINOPHEN 325 mg/1 - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
- BENZHYDROCODONE HYDROCHLORIDE 8.16 mg/1
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- BENZHYDROCODONE HYDROCHLORIDE (UNII: I894QAU7FJ)
- BENZHYDROCODONE (UNII: 75MS0AAZ9I) (Active Moiety)
- ACETAMINOPHEN (UNII: 362O9ITL9D)
- ACETAMINOPHEN (UNII: 362O9ITL9D) (Active Moiety)
What is the NDC to RxNorm Crosswalk for this product?
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: 2001364 - apadaz 6.12 MG / 325 MG Oral Tablet
* Please review the full disclaimer at the bottom of this page.
Patient Education
Benzhydrocodone and Acetaminophen
The combination of benzhydrocodone and acetaminophen is used to relieve severe, acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed) in people who are expected to need an opioid pain medication and whose pain 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.
[Learn More]
Pain Relievers
Pain relievers are medicines that reduce or relieve headaches, sore muscles, arthritis, or other aches and pains. There are many different pain medicines, and each one has advantages and risks. Some types of pain respond better to certain medicines than others. Each person may also have a slightly different response to a pain reliever.
Over-the-counter (OTC) medicines are good for many types of pain. There are two main types of OTC pain medicines: acetaminophen (Tylenol) and nonsteroidal anti-inflammatory drugs (NSAIDs). Aspirin, naproxen (Aleve), and ibuprofen (Advil, Motrin) are examples of OTC NSAIDs.
If OTC medicines don't relieve your pain, your doctor may prescribe something stronger. Many NSAIDs are also available at higher prescription doses. The most powerful pain relievers are opioids. They are very effective, but they can sometimes have serious side effects. There is also a risk of addiction. Because of the risks, you must use them only under a doctor's supervision.
There are many things you can do to help ease pain. Pain relievers are just one part of a pain treatment plan.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
What is the DEA Schedule? This is the assigned DEA Schedule number as reported by the labeler. Values are CI, CII, CIII, CIV, and CV.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".
