Metoclopramide Hydrochloride Tablet, Orally Disintegrating
NDC Package 43386-581-30

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Metoclopramide Hydrochloride tablets is 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)]. This formulation utilizes a tablet, orally disintegrating delivery system. Marketed by Lupin Pharmaceuticals,inc., this product is identified by NDC 43386-581 and is authorized under FDA application ANDA202191.

Identification & Billing

NDC Package Code
43386-581-30
Package Description
10 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
Product Code
43386-581
11-Digit Billing Format
43386058130
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
10 EA
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

Clinical Specifications

Proprietary Name
Metoclopramide Hydrochloride
Non-Proprietary Name
Metoclopramide Hydrochloride
Substance Name
Metoclopramide Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METOCLOPRAMIDE HYDROCHLORIDE 5 mg/1
Pharmacologic Class
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)]

Regulatory & Marketing

Labeler Name
Lupin Pharmaceuticals,inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA202191
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
04-06-2015
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (43386-581). Click a package code to view its specific billing and regulatory data.

43386-581-31
1 BLISTER PACK in 1 CARTON / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 43386-581-30 identifies a specific commercial package of 10 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.. This product is billed for "EA" each discreet unit and contains an estimated amount of 10 billable units per package. This tablet, orally disintegrating is formulated for oral use and contains metoclopramide hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Lupin Pharmaceuticals,inc. on April 06, 2015. The current certification is valid through December 31, 2026.

How is this Lupin Pharmaceuticals,inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43386058130. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 10 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
43386-581-30
11-Digit CMS (5-4-2)
43386-0581-30

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.