Valtoco Spray
NDC Package 72252-520-10

11-digit billing NDC: 72252052010 · Billing unit: EA · 4 EA per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Valtoco (diazepam) sprays is vALTOCO® is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older. This formulation utilizes a spray delivery system. Marketed by Neurelis, Inc, this product is identified by NDC 72252-520 and is authorized under FDA application NDA211635.

Identification & Billing

NDC Package Code
72252-520-10
Package Description
2 BLISTER PACK in 1 CARTON / 2 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE
Product Code
72252-520
11-Digit Billing Format
72252052010
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Valtoco
Non-Proprietary Name
Diazepam
Substance Name
Diazepam
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
Administration Route
Nasal - Administration to the nose; administered by way of the nose.
Active Ingredient(s)
DIAZEPAM 10 mg/.1mL
Pharmacologic Class
Usage Information
VALTOCO® is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 2 years of age and older.
DEA Schedule
Schedule IV (CIV) Substances

Regulatory & Marketing

Labeler Name
Neurelis, Inc
Product Type
Human Prescription Drug
FDA Application #
NDA211635
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
01-10-2020
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (72252-520). Click a package code to view its specific billing and regulatory data.

72252-520-04
2 BLISTER PACK in 1 CARTON / 2 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .1 mL in 1 VIAL, SINGLE-DOSE

* 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 72252-520-10 identifies a specific commercial package of 2 blister pack in 1 carton / 2 vial, single-dose in 1 blister pack / .1 ml in 1 vial, single-dose of Valtoco, a human prescription drug labeled by Neurelis, Inc. This spray is formulated for nasal 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 Neurelis, Inc on January 10, 2020. The current certification is valid through December 31, 2027.

How is this Neurelis, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72252052010. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 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)
72252-520-10
11-Digit CMS (5-4-2)
72252-0520-10

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