Metoclopramide Hydrochloride Tablet, Orally Disintegrating
NDC 43386-581

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 43386-581?
  5. Metoclopramide Hydrochloride Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Metoclopramide Hydrochloride is a ANDA-approved product labeled by Lupin Pharmaceuticals,inc.. This medication is typically used as a dopamine d2 antagonists [moa]. It is supplied as a white tablet, orally disintegrating for oral administration. This product entry covers the primary NDC 43386-581 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
43386-581
Proprietary Name:
Metoclopramide Hydrochloride
Non-Proprietary Name: [1]
Metoclopramide Hydrochloride
Substance Name: [2]
Metoclopramide Hydrochloride
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Lupin Pharmaceuticals,inc.
Labeler Code:
43386
Product Label ID:
7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa
FDA Application Number: [6]
ANDA202191
Marketing Category: [8]
ANDA - A product marketed under an approved Abbreviated New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
04-06-2015
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
WHITE (C48325 - OFF-WHITE)
Shape:
ROUND (C48348)
Size(s):
12 MM
Imprint(s):
N;580
N;581
Score:
1

Code Structure Chart

Product Details

What is NDC 43386-581?

The NDC code 43386-581 is assigned by the FDA to the product Metoclopramide Hydrochloride. This pharmaceutical product is labeled by Lupin Pharmaceuticals,inc. and is currently categorized as listed product. The medication is a tablet, orally disintegrating administered via oral route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 43386-581-30, 43386-581-31. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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)]

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • 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

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Patient Education

Metoclopramide


Metoclopramide is used to relieve heartburn and speed the healing of ulcers and sores in the esophagus (tube that connects the mouth to the stomach) in people who have gastroesophageal reflux disease (GERD; condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus) that did not get better with other treatments. Metoclopramide is also used to relieve symptoms caused by slow stomach emptying in people who have diabetes. These symptoms include nausea, vomiting, heartburn, loss of appetite, and feeling of fullness that lasts long after meals. Metoclopramide is in a class of medications called prokinetic agents. It works by speeding the movement of food through the stomach and intestines.
[Learn More]


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

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".