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  5. NDC Package Code: 35573-439-02 Loxapine

NDC Package 35573-439-02 Loxapine

Capsule Oral - 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:
35573-439-02
Package Description:
100 CAPSULE in 1 BOTTLE
Product Code:
35573-439
Proprietary Name:
Loxapine
Non-Proprietary Name:
Loxapine
Substance Name:
Loxapine Succinate
Usage Information:
Loxapine is used to treat certain mental/mood disorders (such as schizophrenia). This medicine helps you to think more clearly, feel less nervous, and take part in everyday life. It can reduce aggression and the desire to hurt yourself/others. It may also help to decrease hallucinations (such as hearing/seeing things that are not there). Loxapine is a psychiatric medication (antipsychotic type) that works by helping to restore the balance of certain natural substances (such as dopamine) in the brain.
11-Digit NDC Billing Format:
35573043902
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
100 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 311385 - loxapine succinate 25 MG Oral Capsule
  • RxCUI: 311385 - loxapine 25 MG Oral Capsule
  • RxCUI: 311385 - loxapine 25 MG (as loxapine succinate 34 MG) Oral Capsule
  • RxCUI: 311386 - loxapine succinate 5 MG Oral Capsule
  • RxCUI: 311386 - loxapine 5 MG Oral Capsule
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Burel Pharmaceuticals, Llc
    Dosage Form:
    Capsule - A solid oral dosage form consisting of a shell and a filling. The shell is composed of a single sealed enclosure, or two halves that fit together and which are sometimes sealed with a band. Capsule shells may be made from gelatin, starch, or cellulose, or other suitable materials, may be soft or hard, and are filled with solid or liquid ingredients that can be poured or squeezed.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • LOXAPINE SUCCINATE 50 mg/1
    • Sample Package:
    No
    FDA Application Number:
    ANDA076868
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    05-01-2021
    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 35573-439-02?

    The NDC Packaged Code 35573-439-02 is assigned to a package of 100 capsule in 1 bottle of Loxapine, a human prescription drug labeled by Burel Pharmaceuticals, Llc. The product's dosage form is capsule and is administered via oral form.

    Is NDC 35573-439 included in the NDC Directory?

    Yes, Loxapine with product code 35573-439 is active and included in the NDC Directory. The product was first marketed by Burel Pharmaceuticals, Llc on May 01, 2021 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 NDC billing unit for package 35573-439-02?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 100.

    What is the 11-digit format for NDC 35573-439-02?

    The 11-digit format is 35573043902. 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
    5-3-235573-439-025-4-235573-0439-02