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  5. NDC Package Code: 63539-135-02 Zavzpret

NDC Package 63539-135-02 Zavzpret

Zavegepant Spray Nasal - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
63539-135-02
Package Description:
1 BLISTER PACK in 1 CARTON / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK (63539-135-01) / .1 mL in 1 VIAL, SINGLE-DOSE
Product Code:
63539-135
Proprietary Name:
Zavzpret
Non-Proprietary Name:
Zavegepant
Substance Name:
Zavegepant Hydrochloride
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.
11-Digit NDC Billing Format:
63539013502
NDC to RxNorm Crosswalk:
  • RxCUI: 2637974 - zavegepant 10 MG Nasal Spray
  • RxCUI: 2637980 - Zavzpret 10 MG Nasal Spray
  • RxCUI: 2637980 - zavegepant 10 MG Nasal Spray [Zavzpret]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    U.s. Pharmaceuticals
    Dosage Form:
    Spray - A liquid minutely divided as by a jet of air or steam.
    Administration Route(s):
  • Nasal - Administration to the nose; administered by way of the nose.
    • Active Ingredient(s):
  • ZAVEGEPANT HYDROCHLORIDE 10 mg/.1mL
    • Pharmacologic Class(es):
  • Calcitonin Gene-related Peptide Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Calcitonin Gene-related Peptide Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    Yes
    FDA Application Number:
    NDA216386
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    06-01-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 63539-135-02?

    The NDC Packaged Code 63539-135-02 is assigned to a package of 1 blister pack in 1 carton / 1 vial, single-dose in 1 blister pack (63539-135-01) / .1 ml in 1 vial, single-dose of Zavzpret, a human prescription drug labeled by U.s. Pharmaceuticals. The product's dosage form is spray and is administered via nasal form.

    Is NDC 63539-135 included in the NDC Directory?

    Yes, Zavzpret with product code 63539-135 is active and included in the NDC Directory. The product was first marketed by U.s. Pharmaceuticals on June 01, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 63539-135-02?

    The 11-digit format is 63539013502. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-263539-135-025-4-263539-0135-02