Apadaz Tablet
NDC Package 70040-0189-1

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Apadaz (benzhydrocodone and acetaminophen) tablets is 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)]. This formulation utilizes a tablet delivery system. Marketed by Zevra Therapeutics, Inc., this product is identified by NDC 70040-0189 and is authorized under FDA application NDA208653.

Identification & Billing

NDC Package Code
70040-0189-1
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
70040-0189
11-Digit Billing Format
70040018901
RxNorm Crosswalk
  • 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

Clinical Specifications

Proprietary Name
Apadaz
Non-Proprietary Name
Benzhydrocodone And Acetaminophen
Substance Name
Acetaminophen; Benzhydrocodone Hydrochloride
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
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)]
DEA Schedule
Schedule II (CII) Substances

Regulatory & Marketing

Labeler Name
Zevra Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA208653
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
02-23-2018
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 70040-0189-1 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Apadaz, a human prescription drug labeled by Zevra Therapeutics, Inc.. This tablet is formulated for oral use and contains acetaminophen; benzhydrocodone hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Zevra Therapeutics, Inc. on February 23, 2018. The current certification is valid through December 31, 2026.

How is this Zevra Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70040018901. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-4-1)
70040-0189-1
11-Digit CMS (5-4-2)
70040-0189-01

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.