Zavzpret Spray
NDC Package 0069-3500-02

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

Package Information

Zavzpret (zavegepant) sprays is zAVZPRET is indicated for the acute treatment of migraine with or without aura in adults.Limitations of UseZAVZPRET is not indicated for the preventive treatment of migraine. This formulation utilizes a spray delivery system. Marketed by Pfizer Laboratories Div Pfizer Inc, this product is identified by NDC 0069-3500 and is authorized under FDA application NDA216386.

Identification & Billing

NDC Package Code
0069-3500-02
Package Description
6 BLISTER PACK in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (0069-3500-01) / .1 mL in 1 VIAL, SINGLE-DOSE
Product Code
0069-3500
11-Digit Billing Format
00069350002
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Zavzpret
Non-Proprietary Name
Zavegepant
Substance Name
Zavegepant Hydrochloride
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)
ZAVEGEPANT HYDROCHLORIDE 10 mg/.1mL
Pharmacologic Class
Usage Information
ZAVZPRET is indicated for the acute treatment of migraine with or without aura in adults.Limitations of UseZAVZPRET is not indicated for the preventive treatment of migraine.

Regulatory & Marketing

Labeler Name
Pfizer Laboratories Div Pfizer Inc
Product Type
Human Prescription Drug
FDA Application #
NDA216386
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-01-2023
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.

* 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 0069-3500-02 identifies a specific commercial package of 6 blister pack in 1 carton / 1 vial, single-dose in 1 blister pack (0069-3500-01) / .1 ml in 1 vial, single-dose of Zavzpret, a human prescription drug labeled by Pfizer Laboratories Div Pfizer Inc. This spray is formulated for nasal use and contains zavegepant 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 Pfizer Laboratories Div Pfizer Inc on June 01, 2023. The current certification is valid through December 31, 2026.

How is this Pfizer Laboratories Div Pfizer Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00069350002. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 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 (4-4-2)
0069-3500-02
11-Digit CMS (5-4-2)
00069-3500-02

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