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  5. NDC Package Code: 51862-903-01 Clozapine

NDC Package 51862-903-01 Clozapine

Tablet Oral - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
51862-903-01
Package Description:
100 TABLET in 1 BOTTLE
Product Code:
51862-903
Proprietary Name:
Clozapine
Non-Proprietary Name:
Clozapine
Substance Name:
Clozapine
Usage Information:
See also Warning section. This medication is used to treat certain mental/mood disorders (schizophrenia, schizoaffective disorders). Clozapine is a psychiatric medication (anti-psychotic type) that works by helping to restore the balance of certain natural substances (neurotransmitters) in the brain. Clozapine decreases hallucinations and helps prevent suicide in people who are likely to try to harm themselves. It helps you to think more clearly and positively about yourself, feel less nervous, and take part in everyday life.
11-Digit NDC Billing Format:
51862090301
NDC to RxNorm Crosswalk:
  • RxCUI: 197535 - cloZAPine 100 MG Oral Tablet
  • RxCUI: 197535 - clozapine 100 MG Oral Tablet
  • RxCUI: 197536 - cloZAPine 25 MG Oral Tablet
  • RxCUI: 197536 - clozapine 25 MG Oral Tablet
  • RxCUI: 309374 - cloZAPine 200 MG Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Mayne Pharma Commercial Llc
    Dosage Form:
    Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • CLOZAPINE 200 mg/1
    • Pharmacologic Class(es):
  • Atypical Antipsychotic - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA203807
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    10-05-2020
    Listing Expiration Date:
    12-31-2025
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    51862-903-05500 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 51862-903-01?

    The NDC Packaged Code 51862-903-01 is assigned to a package of 100 tablet in 1 bottle of Clozapine, a human prescription drug labeled by Mayne Pharma Commercial Llc. The product's dosage form is tablet and is administered via oral form.

    Is NDC 51862-903 included in the NDC Directory?

    Yes, Clozapine with product code 51862-903 is active and included in the NDC Directory. The product was first marketed by Mayne Pharma Commercial Llc on October 05, 2020 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 51862-903-01?

    The 11-digit format is 51862090301. 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
    5-3-251862-903-015-4-251862-0903-01