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  5. NDC Package Code: 57664-211-13 Clozapine

NDC Package 57664-211-13 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:
57664-211-13
Package Description:
500 TABLET in 1 BOTTLE
Product Code:
57664-211
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:
57664021113
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:
    Sun Pharmaceutical Industries, Inc.
    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:
    ANDA075713
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    11-08-2017
    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
    57664-211-88100 TABLET in 1 BOTTLE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 57664-211-13?

    The NDC Packaged Code 57664-211-13 is assigned to a package of 500 tablet in 1 bottle of Clozapine, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is tablet and is administered via oral form.

    Is NDC 57664-211 included in the NDC Directory?

    Yes, Clozapine with product code 57664-211 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on November 08, 2017 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 57664-211-13?

    The 11-digit format is 57664021113. 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
    5-3-257664-211-135-4-257664-0211-13