Valium Tablet
NDC Package 80725-005-01

11-digit billing NDC: 80725000501 · Billing unit: EA · 100 EA per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Valium (diazepam) tablets is vALIUM is indicated for the:Treatment of anxiety disordersShort-term treatment of anxiety symptomsTreatment of tremor, acute agitation, hallucinosis, and impending delirium tremens or delirium tremens in acute alcohol withdrawalAdjunctive treatment of skeletal muscle spasm due to: reflex spasm to local pathologyspasticity caused by upper motor neuron disordersathetosisstiff-person syndromeAdjunctive treatment of seizure disordersLimitations of UseThe effectiveness of VALIUM for long-term use (greater than 4 months) has not been evaluated.VALIUM is not recommended as maintenance monotherapy for the treatment of seizure disorders. This formulation utilizes a tablet delivery system. Marketed by Waylis Therapeutics Llc, this product is identified by NDC 80725-005 and is authorized under FDA application NDA013263.

Identification & Billing

NDC Package Code
80725-005-01
Package Description
100 TABLET in 1 BOTTLE
Product Code
80725-005
11-Digit Billing Format
80725000501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Valium
Non-Proprietary Name
Diazepam
Substance Name
Diazepam
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)
DIAZEPAM 5 mg/1
Pharmacologic Class
Usage Information
VALIUM is indicated for the:Treatment of anxiety disordersShort-term treatment of anxiety symptomsTreatment of tremor, acute agitation, hallucinosis, and impending delirium tremens or delirium tremens in acute alcohol withdrawalAdjunctive treatment of skeletal muscle spasm due to: reflex spasm to local pathologyspasticity caused by upper motor neuron disordersathetosisstiff-person syndromeAdjunctive treatment of seizure disordersLimitations of UseThe effectiveness of VALIUM for long-term use (greater than 4 months) has not been evaluated.VALIUM is not recommended as maintenance monotherapy for the treatment of seizure disorders.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Waylis Therapeutics Llc
Product Type
Human Prescription Drug
FDA Application #
NDA013263
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
04-04-2022
Listing Expiration
12-31-2027
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.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 80725-005-01 identifies a specific commercial package of 100 tablet in 1 bottle of Valium, a human prescription drug labeled by Waylis Therapeutics Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 100 billable units per package. This tablet is formulated for oral use and contains diazepam 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 Waylis Therapeutics Llc on April 04, 2022. The current certification is valid through December 31, 2027.

How is this Waylis Therapeutics Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80725000501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 total billable units per package. 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 (5-3-2)
80725-005-01
11-Digit CMS (5-4-2)
80725-0005-01

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