Metoclopramide Hydrochloride Solution
NDC Package 62135-526-47

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 solution is the use of Metoclopramide Oral Solution is recommended for adults only. This formulation utilizes a solution delivery system. Marketed by Chartwell Rx, Llc, this product is identified by NDC 62135-526 and is authorized under FDA application ANDA073680.

Identification & Billing

NDC Package Code
62135-526-47
Package Description
473 mL in 1 BOTTLE
Product Code
62135-526
11-Digit Billing Format
62135052647
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk
  • RxCUI: 104884 - metoclopramide 5 MG in 5 mL Oral Solution
  • RxCUI: 104884 - metoclopramide 1 MG/ML Oral Solution
  • RxCUI: 104884 - metoclopramide (as the monohydrochloride monohydrate) 5 MG per 5 ML Oral Solution
  • RxCUI: 104884 - metoclopramide 5 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Metoclopramide Hydrochloride
Non-Proprietary Name
Metoclopramide Hydrochloride
Substance Name
Metoclopramide Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
METOCLOPRAMIDE HYDROCHLORIDE 5 mg/5mL
Pharmacologic Class
Usage Information
The use of Metoclopramide Oral Solution is recommended for adults only. Therapy should not exceed 12 weeks in duration.Symptomatic Gastroesophageal RefluxMetoclopramide Oral Solution is indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy.The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of 12-week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically.Diabetic Gastroparesis (diabetic gastric stasis)Metoclopramide is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals and anorexia) appear to respond to metoclopramide within different time intervals. Significant relief of nausea occurs early and continues to improve over a three-week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.

Regulatory & Marketing

Labeler Name
Chartwell Rx, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA073680
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-27-1992
Listing Expiration
12-31-2027
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 (62135-526). Click a package code to view its specific billing and regulatory data.

62135-526-24
2 TRAY in 1 BOX / 10 CUP in 1 TRAY / 10 mL in 1 CUP (62135-526-10)

* 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 62135-526-47 identifies a specific commercial package of 473 ml in 1 bottle of Metoclopramide Hydrochloride, a human prescription drug labeled by Chartwell Rx, Llc. This solution 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 Chartwell Rx, Llc on October 27, 1992. The current certification is valid through December 31, 2027.

How is this Chartwell Rx, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62135052647. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 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)
62135-526-47
11-Digit CMS (5-4-2)
62135-0526-47

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