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  5. NDC Package Code: 43386-581-31 Metoclopramide Hydrochloride

NDC Package 43386-581-31 Metoclopramide Hydrochloride

Tablet, Orally Disintegrating 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:
43386-581-31
Package Description:
1 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code:
43386-581
Proprietary Name:
Metoclopramide Hydrochloride
Non-Proprietary Name:
Metoclopramide Hydrochloride
Substance Name:
Metoclopramide Hydrochloride
Usage Information:
Metoclopramide Orally Disintegrating Tablets is indicated in adults for the:Treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux disease (GERD) who fail to respond to conventional therapy.Relief of symptoms associated with acute and recurrent diabetic gastroparesis (gastric stasis).Limitations of Use: Metoclopramide Orally Disintegrating Tablets is not recommended for use in pediatric patients due to the risk of developing tardive dyskinesia (TD) and other extrapyramidal symptoms and the risk of methemoglobinemia in neonates [see Use in Specific Populations ( 8.4)]
11-Digit NDC Billing Format:
43386058131
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
1 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 608623 - metoclopramide HCl 10 MG Disintegrating Oral Tablet
  • RxCUI: 608623 - metoclopramide 10 MG Disintegrating Oral Tablet
  • RxCUI: 608623 - metoclopramide 10 MG (metoclopramide hydrochloride 11.82 MG) Disintegrating Oral Tablet
  • RxCUI: 608624 - metoclopramide HCl 5 MG Disintegrating Oral Tablet
  • RxCUI: 608624 - metoclopramide 5 MG Disintegrating Oral Tablet
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Lupin Pharmaceuticals,inc.
    Dosage Form:
    Tablet, Orally Disintegrating - A solid dosage form containing medicinal substances which disintegrates rapidly, usually within a matter of seconds, when placed upon the tongue.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1
    • Pharmacologic Class(es):
  • Dopamine D2 Antagonists - [MoA] (Mechanism of Action)
  • Dopamine-2 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    ANDA202191
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    04-06-2015
    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 43386-581-31?

    The NDC Packaged Code 43386-581-31 is assigned to a package of 1 blister pack in 1 carton / 10 tablet, orally disintegrating in 1 blister pack of Metoclopramide Hydrochloride, a human prescription drug labeled by Lupin Pharmaceuticals,inc.. The product's dosage form is tablet, orally disintegrating and is administered via oral form.This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package.

    Is NDC 43386-581 included in the NDC Directory?

    Yes, Metoclopramide Hydrochloride with product code 43386-581 is active and included in the NDC Directory. The product was first marketed by Lupin Pharmaceuticals,inc. on April 06, 2015 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 43386-581-31?

    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 1.

    What is the 11-digit format for NDC 43386-581-31?

    The 11-digit format is 43386058131. 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
    5-3-243386-581-315-4-243386-0581-31