Home › NDC Lookup › Ingredients › Metoclopramide Hydrochloride › 43386-0581-31

METOCLOPRAMIDE hydrochloride 5 mg Tablet, Orally Disintegrating, 10-count

by Lupin Pharmaceuticals,Inc. · 1 BLISTER PACK in 1 CARTON (43386-581-31) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

NDC 43386-0581-31

🏷️ FDA NDC (as labeled) 43386-581-31 billing pads the product segment with a zero

Rx only Generic On market Non-controlled

🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm

📋 All sources & update times →

This page is curated, coded, and maintained by Dr. Brian Staiger, PharmD

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 43386-581-31

Product NDC 43386-581

11-digit billing NDC 43386058131

NCPDP billing unit EA — each (per item)

RxCUI 608623, 608624

UNII W1792A2RVD

Application # ANDA202191

SPL Set ID 7cd1dc35-2fb2-4f1d-8769-24c3c3aa34fa

Established class (EPC) Dopamine-2 Receptor Antagonist

Mechanism of action Dopamine D2 Antagonists

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2015-04-06

Route ORAL

Dosage form TABLET, ORALLY DISINTEGRATING

Substance METOCLOPRAMIDE HYDROCHLORIDE

GPI-14 52300020107210

GPI class Metoclopramide HCl

GCN Seq No 065803

GCN 27898

HICL code 002148

Ingredient (HICL) Metoclopramide Hcl

HIC1 code J

Therapeutic class — broad (HIC1) Autonomic Nervous System

HIC2 code J9

Therapeutic class — intermediate (HIC2) Drugs Affecting Intestinal Motility

HIC3 code J9A

Therapeutic class — specific (HIC3) Intestinal Motility Stimulants

AHFS code 56:32.00.00

AHFS class Prokinetic Agents

FDB label name METOCLOPRAMIDE HCL 5 MG ODT

FDB brand name Metoclopramide Hcl Odt

Legend status F — Federal legend — prescription drug or device

Why two NDCs? The FDA registers this code as 43386-581-31 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 43386-0581-31. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Dopamine-2 Receptor Antagonist class.

Pharmacologic class Dopamine-2 Receptor Antagonist

Drug family (ATC) Propulsives

How it works Dopamine D2 Antagonists

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerLupin Pharmaceuticals,Inc.

Application holderNOVEL LABORATORIES INC

FDA applicationANDA202191 (ANDA)

Labeler code43386

First marketedApr 2015

Product typeHuman Prescription Drug

Portfolio89 products on file

🔎 All NDCs from Lupin Pharmaceuticals,Inc.

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name METOCLOPRAMIDE HCL 5 MG ODT Ingredient Metoclopramide Hcl

📖 What it is MedlinePlus · NLM

Metoclopramide is used to treat gastroesophageal reflux disease (GERD; condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus) and gastroparesis (slow stomach emptying) . Metoclopramide is in a class of medications called prokinetic agents. It works by speeding the movement of food through the stomach and intestines.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

It helps your digestive system move food along faster. If you have acid reflux, it tightens the valve between your esophagus and stomach so acid is less likely to back up. If you h...
What exactly is metoclopramide supposed to do for me?
This medication is meant to be short-term. For acid reflux, treatment is generally 4 to 12 weeks. For diabetic gastroparesis, it's usually 2 to 8 weeks. Using it longer than recomm...
The most common ones — restlessness, drowsiness, and fatigue — affect roughly 1 in 10 people and are usually manageable. The ones that need urgent attention are any unusual or repe...

📖 Read our full Metoclopramide guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Metoclopramide Hydrochloride — tap one for details:

1,4-butanediolMajor BeerMajor Gamma-hydroxybutyrate (ghb)Major KavaMajor L-tryptophanMajor WineMajor 5-htpModerate AdrueModerate

🌿 Every supplement checked against Metoclopramide Hydrochloride (135 interactions) — ranked by severity →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color white

ShapeRound

ImprintN;581

Size12 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII Z0H242BBR1
Aspartame is an artificial sweetener made from amino acids. It's added to medicines to improve taste, making bitter or unpleasant-tasting drugs easier to take.
UNII REK4960K2U
Butylated hydroxyanisole is a synthetic preservative that prevents oils and fats in medicines from spoiling or becoming rancid. It keeps the medicine stable and extends its shelf life.
UNII 1P9D0Z171K
BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
UNII 2S7830E561
Crospovidone is a synthetic polymer derived from povidone. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active ingredient can be absorbed.
UNII 905HNO1SIH
A synthetic polymer made from methacrylate compounds that forms a film coating on tablets or capsules. It helps control how quickly the medicine dissolves and releases its active ingredient in the digestive system.
UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
UNII E4GA8884NN
Phosphoric acid is a weak mineral acid used in medicines as a buffer and pH adjuster. It helps stabilize the product and control its acidity level.
UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$7.43	$74.28 / 10 tablets

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
METOCLOPRAMIDE hydrochloride 5 mgthis 43386-0581-31	Lupin	10 tablets	—	—	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2015

On the market since

Apr 2015

📍

2026

Currently FDA-listed

11 years listed

🔓

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Metoclopramide Hydrochloride — the ingredient across all brands.

Top reported reactions

Tardive Dyskinesia16,218

Extrapyramidal Disorder12,921

Nervous System Disorder7,526

Dystonia7,115

Nausea6,495

Pain5,969

Vomiting4,940

Age at onset

Neonate240

Infant83

Child168

Adolescent169

Adult5,074

Elderly3,544

Reporter sex

Male · 36%

Female · 62%

Unknown · 2%

Reports over time (by year) — tap or hover for the count & year

Most recent year is provisional (FAERS lags ~3 months).

Where does this data come from?

Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
43386-0581-31 You're viewing this	1 BLISTER PACK in 1 CARTON (43386-581-31) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK	2015-04-06	Active

🧭 About this NDC listing & data coverage

Finished prescription product

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 43386-581-31, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 43386-0581-31, written without dashes as 43386058131. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 43386-0581-31, the first segment (43386) is the labeler code FDA assigned to Lupin Pharmaceuticals,Inc.; the middle segment (0581) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (31) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Lupin Pharmaceuticals,Inc.. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

Lupin Pharmaceuticals,Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide

🚨 Boxed Warning 205 words ▾

WARNING TARDIVE DYSKINESIA Metoclopramide Orally Disintegrating Tablets can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage [see Warnings and Precautions (5.1)].

Discontinue Metoclopramide Orally Disintegrating Tablets in patients who develop signs or symptoms of TD. In some patients, symptoms may lessen or resolve after Metoclopramide Orally Disintegrating Tablets is stopped [see Warnings and Precautions (5.1)]. Avoid treatment with Metoclopramide Orally Disintegrating Tablets for longer than 12 weeks because of the increased risk of developing TD with longer-term use [see Warnings and Precautions (5.1), Dosage and Administration (2.2, 2.3)].

WARNING: TARDIVE DYSKINESIA Metoclopramide Orally Disintegrating Tablets can cause tardive dyskinesia (TD), a serious movement disorder that is often irreversible. There is no known treatment for TD. The risk of developing TD increases with duration of treatment and total cumulative dosage.

( 5.1 ) Discontinue Metoclopramide Orally Disintegrating Tablets in patients who develop signs or symptoms of TD. ( 5.1 ) Avoid treatment with Metoclopramide Orally Disintegrating Tablets for longer than 12 weeks because of the risk of developing TD with longer-term use. ( 5.1 , 2.1 , 2.2 , 2.3 )

🎯 Indications and Usage 171 words ▾

1 INDICATIONS AND USAGE 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 )] Metoclopramide Orally Disintegrating Tablets is a dopamine-2 (D2) antagonist indicated in adults for: Treatment of symptomatic, documented gastroesophageal reflux disease (GERD) in adults with 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. (1, 8.4 )

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION GERD The recommended dosage is 10 mg to 15 mg up to four times daily at least 30 minutes before eating and at bedtime for 4 to 12 weeks. ( 2.2 ) Diabetic Gastroparesis (Gastric Stasis) The recommended dosage is 10 mg dose four times daily at least 30 minutes before eating and at bedtime for 2 to 8 weeks. ( 2.3 ) Dosage Adjustment in Specific Populations See Full Prescribing Information for recommended dosage reductions for elderly patients, patients with moderate or severe hepatic or renal impairment, and cytochrome P450 2D6 (CYP2D6) poor metabolizers.

( 2.2 , 2.3 )

2.1Important Administration Instructions Avoid treatment with Metoclopramide Orally Disintegrating Tablets for longer than 12 weeks because of the increased risk of developing TD with longer-term use [see Dosage and Administration ( 2.2 , 2.3), Warnings and Precautions ( 5.1 )]. Take on an empty stomach at least 30 minutes before eating [see Clinical Pharmacology ( 12.3 )]. Do not repeat dose if inadvertently taken with food.

Remove each dose from the packaging just prior to taking. Handle the tablet with dry hands and place on the tongue. If the tablet should break or crumble while handling, discard and remove a new tablet.

Place the tablet on the tongue and allow it to disintegrate (takes approximately one minute) and swallow the granules without water [see Clinical Pharmacology ( 12.3 )].

2.2Dosage for GERD Metoclopramide Orally Disintegrating Tablets may be administered continuously or intermittently in patients with symptomatic GERD who fail to respond to conventional therapy: Continuous Dosing The recommended adult dosage of Metoclopramide Orally Disintegrating Tablets is 10 to 15 mg four times daily for 4 to 12 weeks. The treatment duration is determined by endoscopic response. Administer the dosage thirty minutes before each meal and at bedtime.

The maximum recommended daily dosage is 60 mg. Table 1 displays the recommended daily dosage and maximum daily dosage for adults and dosage adjustments for patients with moderate or severe hepatic impairment (Child-Pugh B or C), in patients with creatinine clearance less than 60 mL/minute, in cytochrome P450 2D6 (CYP2D6) poor metabolizers, and with concomitant use with strong CYP2D6 inhibitors. Intermittent Dosing If symptoms only occur intermittently or at specific times of the day, administer Metoclopramide Orally Disintegrating Tablets in single dose up to 20 mg prior to the provoking situation.

Consider dosage reductions for the populations and situations in Table 1. Table 1 Recommended Metoclopramide Orally Disintegrating Tablets Dosage in Patients with Gastroesophageal Reflux Recommended Dosage Maximum Recommended Daily Dosage Adult patients 10 to 15 mg four times daily (thirty minutes before each meal and at bedtime) 60 mg Mild hepatic impairment (Child-Pugh A) Elderly patients1 [see Use in Specific Populations ( 8.5 )] 5 mg four times daily (thirty minutes before each meal and at bedtime) Moderate or severe hepatic impairment (Child-Pugh B or C) [see Use in Specific Populations ( 8.7 )] 5 mg four times daily (thirty minutes before each meal and at bedtime), or 10 mg taken three times daily 30 mg CYP2D6 poor metabolizers [see Use in Specific Populations ( 8.9 )] Concomitant use with strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) [see Drug Interactions ( 7.1 )] Moderate or severe renal impairment (creatinine clearance less than or equal to 60 mL/minute) [see Use in Specific Populations ( 8.6 )] Patients with End-Stage Renal Disease (ESRD) including those treated with hemodialysis and continuous ambulatory peritoneal dialysis [see Use in Specific Populations ( 8.6 )] 5 mg four times daily (thirty minutes before each meal and at bedtime) or 10 mg twice daily 20 mg 1 Elderly patients may be more sensitive to the therapeutic or adverse effects of Metoclopramide Orally Disintegrating Tablets; therefore, consider a lower starting dosage of 5 mg four ti…

💊 Dosage Forms and Strengths 75 words ▾

3 DOSAGE FORMS AND STRENGTHS Tablets: 5 mg Tablets: Metoclopramide Orally Disintegrating Tablets are round, white to off- white, flat faced beveled edge tablet, debossed with 'N' on one side and "581" on the other side. 10 mg Tablets: Metoclopramide Orally Disintegrating Tablets are round, white to off- white, flat faced beveled edge tablet, debossed with 'N' on one side and "580" on the other side. Orally Disintegrating Tablets: 5 mg and 10 mg metoclopramide.

⛔ Contraindications 154 words ▾

4 CONTRAINDICATIONS Metoclopramide Orally Disintegrating Tablets is contraindicated: In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide [see Warnings and Precautions (5.1, 5.2)]. When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation). In patients with pheochromocytoma or other catecholamine-releasing paragangliomas.

Reglan may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor [ see Warnings and Precautions (5.5 )]. In patients with epilepsy. Reglan may increase the frequency and severity of seizures [see Adverse Reactions (6) ].

In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm [see Adverse Reactions (6) ]. History of TD or dystonic reaction to metoclopramide ( 4 ) When stimulation of gastrointestinal motility might be dangerous ( 4 ) Pheochromocytoma, catecholamine-releasing paragangliomas ( 4 ) Epilepsy ( 4 ) Hypersensitivity to metoclopramide ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Tardive Dyskinesia (TD), Other Extrapyramidal Symptoms (EPS), and Neuroleptic Malignant Syndrome (NMS): Avoid concomitant use of other drugs known to cause TD/EPS/NMS and avoid use in patients with Parkinson's disease. If symptoms occur, discontinue Metoclopramide Orally Disintegrating Tablets and seek immediate medical attention. ( 5.1 , 5.2 , 5.3 , 7.1 , 7.2 ) Depression and suicidal ideation/suicide : Avoid use. ( 5.4 )

5.1Tardive Dyskinesia Metoclopramide can cause tardive dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities. Movements may be choreoathetoic in appearance. The risk of developing TD and the likelihood that TD will become irreversible increases with the duration of treatment and total cumulative dosage.

An analysis of utilization patterns showed that about 20% of patients who used metoclopramide took it for longer than 12 weeks. Treatment with metoclopramide for longer than the recommended 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD. Additionally, the risk of developing TD is increased among the elderly, especially elderly women [see Use in Specific Populations (8.5 )] , and in patients with diabetes mellitus.

Due to the risk of developing TD, avoid treatment with Metoclopramide Orally Disintegrating Tablets for longer than 12 weeks and reduce the dosage in elderly patients [see Dosage and Administration ( 2.2 , 2.3 )]. Discontinue Metoclopramide Orally Disintegrating Tablets immediately in patients who develop signs and symptoms of TD. There is no known effective treatment for established cases of TD, although in some patients TD may remit, partially or completely, within several weeks to months after Metoclopramide Orally Disintegrating Tablets is withdrawn.

Metoclopramide Orally Disintegrating Tablets itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown. Metoclopramide Orally Disintegrating Tablets is contraindicated in patients with a history of TD [see Contraindications (4) ].

Avoid Metoclopramide Orally Disintegrating Tablets in patients receiving other drugs that can cause TD (e.g., antipsychotics).

5.2Other Extrapyramidal Symptoms In addition to TD, metoclopramide may cause other extrapyramidal symptoms (EPS), parkinsonian symptoms, and motor restlessness. Advise patients to seek immediate medical attention if such symptoms occur and to discontinue Metoclopramide Orally Disintegrating Tablets. Extrapyramidal symptoms (EPS), such as acute dystonic reactions, occurred in patients treated with metoclopramide dosages of 30 to 40 mg daily.

Such reactions occurred more frequently in adults less than 30 years of age and at higher than recommended dosages. EPS occurred more frequently in pediatric patients compared to adults (Metoclopramide Orally Disintegrating Tablets is not approved for use in pediatric patients). Symptoms can occur in the first 24 to 48 hours after starting metoclopramide.

Symptoms included involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions were present as stridor and dyspnea, possibly due to laryngospasm. Diphenhydramine hydrochloride or benztropine mesylate may be used to treat these adverse reactions.

Avoid Metoclopramide Orally Disintegrating Tablets in patients receiving other drugs that can cause EPS (e.g., antipsychotics). Parkinsonism symptoms (bradykinesia, tremor, cogwheel rigidity, mask-like facies) have occurred after starting metoclopramide, more commonly within the first 6 months, but also after longer periods. Symptoms generally have subsided…

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are described, or described in greater detail, in other sections of the labeling: Tardive dyskinesia [see Boxed Warning and Warnings and Precautions ( 5.1 )] Other extrapyramidal effects [see Warnings and Precautions ( 5.2 )] Neuroleptic malignant syndrome [see Warnings and Precautions ( 5.3 )] Depression [see Warnings and Precautions ( 5.4 )] Hypertension [see Warnings and Precautions ( 5.5 )] Fluid retention [see Warnings and Precautions ( 5.6 )] Hyperprolactinemia [see Warnings and Precautions ( 5.7 )] Effects on the ability to drive and operate machinery [see Warnings and Precautions (5.8) ] Metoclopramide The following adverse reactions have been identified from clinical studies or postmarketing reports of metoclopramide.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common adverse reactions (in approximately 10% of patients receiving 10 mg of metoclopramide four times daily) were restlessness, drowsiness, fatigue, and lassitude. In general, the incidence of adverse reactions correlated with the dosage and duration of metoclopramide administration.

Adverse reactions, especially those involving the nervous system, occurred after stopping metoclopramide including dizziness, nervousness, and headaches. Central Nervous System Disorders Tardive dyskinesia, acute dystonic reactions, drug-induced parkinsonism, akathisia, and other extrapyramidal symptoms Convulsive seizures Hallucinations Restlessness, drowsiness, fatigue, and lassitude occurred in approximately 10% of patients who received 10 mg four times daily. Insomnia, headache, confusion, dizziness, or depression with suicidal ideation occurred less frequently Neuroleptic malignant syndrome, serotonin syndrome (in combination with serotonergic agents) Endocrine Disorders : Fluid retention secondary to transient elevation of aldosterone.

Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia Cardiovascular Disorders : Acute congestive heart failure, possible atrioventricular block, hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention Gastrointestinal Disorders : Nausea, bowel disturbances (primarily diarrhea) Hepatic Disorders : Hepatotoxicity, characterized by, e.g., jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential Renal and Urinary Disorders : Urinary frequency, urinary incontinence Hematologic Disorders : Agranulocytosis, neutropenia, leukopenia, methemoglobinemia, sulfhemoglobinemia Hypersensitivity Reactions : Bronchospasm (especially in patients with a history of asthma), urticaria; rash; angioedema, including glossal or laryngeal edema Eye Disorders : Visual disturbances Metabolism Disorders : Porphyria Most common adverse reactions (> 10%) are restlessness, drowsiness, fatigue, and lassitude.

To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-866-403-7592 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Antipsychotics: Potential for additive effects, including TD, EPS, and NMS ; avoid concomitant use. ( 7.1 ) CNS depressants : Increased risk of CNS depression; avoid concomitant use and monitor for adverse reactions. ( 7.1 ) Strong CYP2D6 inhibitors (e.g., quinidine, bupropion, fluoxetine, and paroxetine) : See Full Prescribing Information for recommended dosage reductions.

( 2.2 , 2.3 , 7.1 ) MAO inhibitors : Increased risk of hypertension; avoid concomitant use. ( 5.5 , 7.1 ) Additional drug interactions : See Full Prescribing Information. ( 7.1 , 7.2 )

7.1Effects of Other Drugs on Metoclopramide Table 3 displays the effects of other drugs on metoclopramide. Antipsychotics Clinical Impact Potential for additive effects, including increased frequency and severity of tardive dyskinesia (TD), other extrapyramidal symptoms (EPS), and neuroleptic malignant syndrome (NMS). Intervention Avoid concomitant use [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )].

Strong CYP2D6 Inhibitors, not Included in Antipsychotic Category Above Clinical Impact Increased plasma concentrations of metoclopramide; risk of exacerbation of extrapyramidal symptoms [see Clinical Pharmacology ( 12.3 )]. Intervention Reduce the Metoclopramide Orally Disintegrating Tablets dosage [ see Dosage and Administration ( 2.2 , 2.3 )] . Examples quinidine, bupropion, fluoxetine, and paroxetine.

Monoamine Oxidase Inhibitors Clinical Impact Increased risk of hypertension [see Warnings and Precautions (5.5) ]. Intervention Avoid concomitant use. Central Nervous System (CNS) Depressants Clinical Impact Increased risk of CNS depression [see Warnings and Precautions (5.8) ].

Intervention Avoid Metoclopramide Orally Disintegrating Tablets or the interacting drug, depending on the importance of the drug to the patient. Examples alcohol, sedatives, hypnotics, opiates and anxiolytics. Drugs that Impair Gastrointestinal Motility Clinical Impact Decreased systemic absorption of metoclopramide.

Intervention Monitor for reduced therapeutic effect. Examples antiperistaltic antidiarrheal drugs, anticholinergic drugs, and opiates. Dopaminergic Agonists and Other Drugs that Increase Dopamine Concentrations Clinical Impact Decreased therapeutic effect of metoclopramide, a D2 antagonist, due to opposing effects on dopamine.

Intervention Monitor for reduced therapeutic effect. Examples Apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine.

7.2Effects of Metoclopramide on Other Drugs Table 4 displays the effects of metoclopramide on other drugs. Dopaminergic Agonists and Other Drugs that Increase Dopamine Concentrations: Clinical Impact Opposing effects of metoclopramide and the interacting drug on dopamine. Potential exacerbation of symptoms (e.g., parkinsonian symptoms).

Intervention Avoid concomitant use [see Warnings and Precautions (5.2) ] . Examples Apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, rotigotine. Succinylcholine, Mivacurium: Clinical Impact Metoclopramide inhibits plasma cholinesterase leading to enhanced neuromuscular blockade.

Intervention Monitor for signs and symptoms of prolonged neuromuscular blockade. Drugs with Absorption Altered due to Increased Gastrointestinal Motility: Clinical Impact The effect of metoclopramide on other drugs is variable. Increased gastrointestinal (GI) motility by metoclopramide may impact absorption of other drugs leading to decreased or increased drug exposure.

Intervention Drugs with Decreased Absorption (e.g., digoxin, atovaquone, posaconazole oral suspension*, fosfomycin) : Monitor for reduced therapeutic effect of the interacting drug. For digoxin monitor therapeutic drug concentrations and increase the digoxin dose as needed (see prescribing information for digoxin). Drugs with Increased Absorption (e.g., sirolimus, tacrolimus, cyclosporine) : Monitor therapeutic drug concentrations and adjust the dose as needed.

See prescribing information for th…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Published studies, including retrospective cohort studies, national registry studies, and meta-analyses, do not report an increased risk of adverse pregnancy-related outcomes with use of metoclopramide during pregnancy. There are potential risks to the neonate following exposure in utero to metoclopramide during delivery (see Clinical Considerations) . In animal reproduction studies, no adverse developmental effects were observed with oral administration of metoclopramide to pregnant rats and rabbits at exposures about 6 and 12 times the maximum recommended human dose (MRHD) (see Data) .

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations Fetal/Neonatal Adverse Reactions Metoclopramide crosses the placental barrier and may cause extrapyramidal signs and methemoglobinemia in neonates with maternal administration during delivery. Monitor neonates for extrapyramidal signs [see Warnings and Precautions ( 5.1 , 5.2 ), Use in Specific Populations ( 8.4 )] . Data Animal Data Reproduction studies have been performed following administration of oral metoclopramide during organogenesis in pregnant rats at about 6 times the MRHD calculated on body surface area and in pregnant rabbits at about 12 times the MRHD calculated on body surface area.

No evidence of adverse developmental effects due to metoclopramide were observed.

8.6Lactation Risk Summary Limited published data report the presence of metoclopramide in human milk in variable amounts. Breastfed infants exposed to metoclopramide have experienced gastrointestinal adverse reactions, including intestinal discomfort and increased intestinal gas formation (see Data) . Metoclopramide elevates prolactin levels [see Warnings and Precautions ( 5.7 )] ; however, the published data are not adequate to support drug effects on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Metoclopramide Orally Disintegrating Tablets and any potential adverse effects on the breastfed child from Metoclopramide Orally Disintegrating Tablets or from the underlying maternal condition. Clinical Considerations Monitor breastfeeding neonates because metoclopramide may cause extrapyramidal signs (dystonias) and methemoglobinemia [see Warnings and Precautions ( 5.1 , 5.2 ), Use in Specific Populations ( 8.4 )] .

Data In published clinical studies, the estimated amount of metoclopramide received by the breastfed infant was less than 10% of the maternal weight-adjusted dose. In one study, the estimated daily amount of metoclopramide received by infants from breast milk ranged from 6 to 24 mcg/kg/day in early puerperium (3 to 9 days postpartum) and from 1 to 13 mcg/kg/day at 8 to 12 weeks postpartum.

8.4Pediatric Use Metoclopramide Orally Disintegrating Tablets is not recommended for use in pediatric patients due to the risk of tardive dyskinesia (TD) and other extrapyramidal symptoms as well as the risk of methemoglobinemia in neonates. The safety and effectiveness of Metoclopramide Orally Disintegrating Tablets in pediatric patients have not been established. Dystonias and other extrapyramidal reactions associated with metoclopramide are more common in the pediatric patients than in adults [see Warnings and Precautions ( 5.1 , 5.2 )] .

In addition, neonates have reduced levels of NADH-cytochrome b5 reductase, making them more susceptible to methemoglobinemia, a possible side effect of metoclopramide use in neonates [see Use in Specific Populations ( 8.8 )] .

8.5 Geriatric Use Metoclopramide is known to be substantially excreted b…

🤰 Pregnancy ~1 min read ▾

No evidence of adverse developmental effects due to metoclopramide were observed.

🧒 Pediatric Use 114 words ▾

🧓 Geriatric Use 92 words ▾

8.5Geriatric Use Metoclopramide is known to be substantially excreted by the kidney, and the risk of adverse reactions, including tardive dyskinesia (TD), may be greater in patients with impaired renal function [see Use in Specific Populations ( 8.6 ), Clinical Pharmacology (12.3)] . Elderly patients are more likely to have decreased renal function and may be more sensitive to the therapeutic or adverse effects of metoclopramide; therefore, consider a reduced dosage of METOZOLOV ODT in elderly patients [see Dosage and Administration ( 2.2 , 2.3 ), Warnings and Precautions (5.1) ].

🆘 Overdosage 114 words ▾

10 OVERDOSAGE Manifestations of metoclopramide overdosage included drowsiness, disorientation, extrapyramidal reactions, other adverse reactions associated with metoclopramide use (including, e.g., methemoglobinemia), and sometimes death. Neuroleptic malignant syndrome (NMS) has been reported in association with metoclopramide overdose and concomitant treatment with another drug associated with NMS [see Warnings and Precautions ( 5.1 , 5.2 , 5.3 )]. There are no specific antidotes for Metoclopramide Orally Disintegrating Tablets overdosage.

If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage. Methemoglobinemia can be reversed by the intravenous administration of methylene blue. However, methylene blue may cause hemolytic anemia in patients with G6PD deficiency, which may be fatal.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. The exact mechanism of action of metoclopramide in the treatment of gastroesophageal reflux and acute and recurrent diabetic gastroparesis has not been fully established. It seems to sensitize tissues to the action of acetylcholine.

The effect of metoclopramide on motility is not dependent on intact vagal innervation, but it can be abolished by anticholinergic drugs. Metoclopramide increases the tone and amplitude of gastric (especially antral) contractions, relaxes the pyloric sphincter and the duodenal bulb, and increases peristalsis of the duodenum and jejunum resulting in accelerated gastric emptying and intestinal transit. It increases the resting tone of the lower esophageal sphincter.

It has little, if any, effect on the motility of the colon or gallbladder.

12.2Pharmacodynamics Gastroesophageal Reflux In patients with gastroesophageal reflux and low lower esophageal sphincter pressure (LESP), single oral doses of Reglan produced dose-related increases in LESP. Effects began at about 5 mg and increased through 20 mg. The increase in LESP from a 5 mg dose lasted about 45 minutes and that of 20 mg lasted between 2 and 3 hours. Increased rate of stomach emptying was observed with single oral doses of 10 mg.

12.3Pharmacokinetics Unless otherwise specified the PK of metoclopramide described below was obtained using other oral formulations of metoclopramide. Absorption Relative to an intravenous dose of 20 mg, the absolute oral bioavailability of metoclopramide was 80% ± 15.5% as demonstrated in a crossover study of 18 subjects. Following Metoclopramide Orally Disintegrating Tablets tablet administration, the time reported between placing the tablet on the tongue and it completely disintegrated into fine particles was approximately one minute (with a range of 10 seconds to 14 minutes) in two clinical trials (N = 96) with a mean ± SD being 77 ± 111 seconds and a median of 54 seconds [see Dosage and Administration ( 2.1 )] .

Peak plasma concentrations occurred at about 1 to 2 hours after a single oral dose. Similar time to peak is observed after individual doses at steady state. In a single dose study of 12 subjects showed that the area under the drug concentration-time curve increases linearly with doses from 20 to 100 mg of metoclopramide (5 times the maximum recommended single dose of Metoclopramide Orally Disintegrating Tablets).

Cmax increased linearly with dose; Tmax remained the same; whole body clearance was unchanged; and the elimination rate remained the same. Linear kinetic processes adequately describe the absorption and elimination of metoclopramide. The pharmacokinetic characteristics following single oral administration of 10 mg Metoclopramide Hydrochloride Orally Disintegrating Tablets under fasting conditions are shown in Table 5.

Table 5 Mean (± SD) Pharmacokinetic Parameters in Healthy Subjects Following a Single Oral Dose of 10 mg Metoclopramide Orally Disintegrating Tablets Under Fasting Conditions Treatment C max (ng/mL) T max (h)* AUC 0-inf (ng*h/mL) Single 10 mg Metoclopramide Orally Disintegrating Tablets (N=41) 28±7.4 2.0 (0.7 to 4.0) 268±72.6 *presented as median (range). Effect of Food When Metoclopramide Orally Disintegrating Tablets was taken immediately after a high-fat meal (approximately 900 total calories based on the composition being 150 protein calories, 250 carbohydrate calories and 500 fat calories), the Cmax was 17% lower than when taken after an overnight fast.

The Tmax increased from about 1.8 hours under fasted conditions to 3 hours when taken immediately after a high-fat meal. The extent of metoclopramide absorbed (area under the curve) was comparable whether Metoclopramide Orally Disintegrating Tablets was administered with or without food. The clinical relevance of a lower Cmax with a high-fat meal…

🧬 Mechanism of Action 133 words ▾

It has little, if any, effect on the motility of the colon or gallbladder.

📦 How Supplied / Storage and Handling 132 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Metoclopramide Orally Disintegrating Tablets 5 mg strength are round, white to off- white, flat faced beveled edge tablet debossed with 'N' on one side and "581" on the other side; it is comprised of 5 mg metoclopramide (as 5.91 mg of metoclopramide hydrochloride). These are packaged in blister cards as follows: Box of 10 (1x10) NDC 43386-581-31 Metoclopramide Orally Disintegrating Tablets 10 mg are round, white to off-white, flat faced beveled edge tablet debossed with 'N' on one side and "580" on the other side; it is comprised of 10 mg metoclopramide (as 11.82 mg of metoclopramide hydrochloride).

These are packaged in blister cards as follows: Box of 10 (1x10) NDC 43386-580-31 Tablets should be stored at controlled room temperature, between 20°C and 25°C (68°F and 77°F).

📋 Description 150 words ▾

11 DESCRIPTION Metoclopramide hydrochloride, the active ingredient of Metoclopramide Orally Disintegrating Tablets, is a dopamine-2 (D2) antagonist. Metoclopramide hydrochloride (metoclopramide monohydrochloride monohydrate), is a white or almost white crystalline powder, freely soluble in water. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate.

The molecular formula is C14H22ClN3O2•HCl•H2O. Its molecular weight is 354.3. The structural formula is: Metoclopramide Orally Disintegrating Tablets is an orally disintegrating tablet for oral administration and is available in 5 mg and 10 mg strengths.

Each Metoclopramide Orally Disintegrating Tablets 5 mg tablet contains 5 mg metoclopramide (equivalent to 5.91 mg of metoclopramide hydrochloride USP). Each Metoclopramide Orally Disintegrating Tablets 10 mg tablet contains 10 mg metoclopramide (equivalent to 11.82 mg metoclopramide hydrochloride USP). Metoclopramide Orally Disintegrating Tablets includes the following inactive ingredients: phosphoric acid, mannitol and starch, microcrystalline cellulose, colloidal silicon dioxide, amino methacrylate copolymer, butylated hydroxyanisole, butylated hydroxytoluene, crospovidone, aspartame, N-C mint flavor, magnesium stearate.

Metoclopramide

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Adverse Reactions Inform patients or their caregivers that Metoclopramide Orally Disintegrating Tablets can cause serious adverse reactions. Instruct patients to discontinue Metoclopramide Orally Disintegrating Tablets and contact a healthcare provider immediately if the following serious reactions occur: Tardive dyskinesia and other extrapyramidal reactions [see Warnings and Precautions ( 5.1 , 5.2 )] Neuroleptic malignant syndrome [see Warnings and Precautions ( 5.3 )] Depression and/or possible suicidal ideation [see Warnings and Precautions ( 5.4 )] Inform patients or their caregivers that concomitant treatment with numerous other medications can precipitate or worsen serious adverse reactions such as tardive dyskinesia or other extrapyramidal reactions, neuroleptic malignant syndrome, and CNS depression [see Drug Interactions ( 7.1 , 7.2 )] .

Explain that the prescriber of any other medication must be made aware that the patient is taking Metoclopramide Orally Disintegrating Tablets. Inform patients or their caregivers that Metoclopramide Orally Disintegrating Tablets can cause drowsiness or dizziness, or otherwise impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle [see Warnings and Precautions (5.8) ] . Administration Instruct patients to: Take on an empty stomach at least 30 minutes before eating.

Do not repeat dose if inadvertently taken with food. Remove each dose from the packaging just prior to taking. Handle the tablet with dry hands and place on the tongue.

If the tablet should break or crumble while handling, discard and remove a new tablet. Place the tablet on the tongue and allow it to disintegrate (takes approximately one minute) and swallow the granules without water [see Dosage and Administration (2.1) ]. Manufactured by: Novel Laboratories, Inc.

Somerset, NJ 08873 USA Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 PI5800000203 SAP code: 260278 Rev. 10/2019

💬 Medication Guide ~3 min read ▾

SPL MEDGUIDE Metoclopramide Orally Disintegrating Tablets (MET-oh-KLOE-pra-mide) Read this Medication Guide before you start taking Metoclopramide Orally Disintegrating Tablets and each time you get a refill. There may be new information. If you take another product that contains metoclopramide (such as REGLAN tablets, REGLAN ODT, REGLAN injection or metoclopramide oral solution), you should read the Medication Guide that comes with that product.

Some of the information may be different. This Medication Guide does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about Metoclopramide Orally Disintegrating Tablets?

Metoclopramide Orally Disintegrating Tablets can cause serious side effects, including: Tardive dyskinesia (abnormal muscle movements) . These movements happen mostly in the face muscles. You cannot control these movements.

They may not go away even after stopping Metoclopramide Orally Disintegrating Tablets. There is no treatment for tardive dyskinesia, but symptoms may lessen or go away over time after you stop taking Metoclopramide Orally Disintegrating Tablets. Your chances for getting tardive dyskinesia go up: the longer you take Metoclopramide Orally Disintegrating Tablets and the more Metoclopramide Orally Disintegrating Tablets you take.

You should not take Metoclopramide Orally Disintegrating Tablets for more than 12 weeks. if you are older, especially if you are an older woman. if you have diabetes. It is not possible for your doctor to know if you will get tardive dyskinesia if you take Metoclopramide Orally Disintegrating Tablets. Call your doctor right away if you have movements you cannot stop or control, such as: lip smacking, chewing, or puckering of your lips frowning or scowling sticking out your tongue blinking and moving your eyes shaking of your arms and legs See the section "What are the possible side effects of Metoclopramide Orally Disintegrating Tablets?" for more information about side effects.

What is Metoclopramide Orally Disintegrating Tablets? Metoclopramide Orally Disintegrating Tablets is a prescription medicine used in adults: for 4 to 12 weeks to relieve heartburn symptoms of gastroesophageal reflux disease (GERD) when certain other treatments do not work. to relieve the symptoms of slow stomach emptying in people with diabetes. Metoclopramide Orally Disintegrating Tablets is not recommended for use in children.

Do not take Metoclopramide Orally Disintegrating Tablets if you: have a history of tardive dyskinesia or have a problem controlling your muscles and movements after taking Metoclopramide Orally Disintegrating Tablets or a medicine that works like Metoclopramide Orally Disintegrating Tablets. have stomach or intestine problems that could get worse with Metoclopramide Orally Disintegrating Tablets, such as bleeding, blockage or a tear in your stomach or bowel wall. have a type of tumor that can cause high blood pressure such as pheochromocytoma. have epilepsy (seizures).

Metoclopramide Orally Disintegrating Tablets can increase your chance for seizures and make them worse. are allergic to metoclopramide or any of the ingredients in Metoclopramide Orally Disintegrating Tablets. Metoclopramide Orally Disintegrating Tablets can cause serious allergic reactions. Stop taking Metoclopramide Orally Disintegrating Tablets right away and get emergency help if you have any of these symptoms: swelling of your tongue, throat, lips, eyes or face. trouble swallowing or breathing. skin rash, hives, sores in your mouth, or skin blisters.

See the end of this Medication Guide for a list of ingredients in Metoclopramide Orally Disintegrating Tablets. Before you take Metoclopramide Orally Disintegrating Tablets, tell your doctor about all of your medical conditions, including if you: have kidney or liver disease. had problems controlling your muscle movements after taking any medicine. have depression…

Glossary — plain-language definitions of medical terms used in this label:

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

serotonergic: Acting on serotonin, a chemical messenger involved in mood, sleep, and digestion.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

Active ingredient: The part of a medicine that produces its intended effect on the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

agranulocytosis: A severe drop in a certain type of infection-fighting white blood cell, greatly raising the risk of serious infections.

akathisia: A feeling of inner restlessness and an urgent need to keep moving, making it hard to sit still.

amenorrhea: The absence of monthly menstrual periods.

anemia: A low level of red blood cells or the oxygen-carrying protein inside them, which can cause tiredness, weakness, and paleness.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

atrioventricular block: A slowing or blocking of the electrical signals traveling between the heart's upper and lower chambers, which can slow the heartbeat.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

Boxed Warning: The strongest safety warning the FDA can require, set inside a bold black border because the risk it describes can be very serious.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

bradykinesia: Slowness of movement that makes everyday actions take longer to start and finish.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

Child-Pugh: A scoring system doctors use to grade how severe long-term liver disease is, often to help set the right medicine dose.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

Cmax: The highest level a medicine reaches in the blood after a dose is taken.

CNS depression: A slowing of brain and nervous-system activity that can cause drowsiness, slowed breathing, or reduced alertness.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

crossover: A study design in which each person takes one treatment for a time, then switches to the other, acting as their own comparison.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

depression: A lasting low mood with loss of interest that affects everyday life.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyskinesia: Involuntary, uncontrolled movements of the face, arms, legs, or body.

dyspnea: The medical word for shortness of breath, or the feeling that you cannot get enough air.

edema: Swelling caused by extra fluid trapped in the body's tissues.

Elimination: The overall removal of a medicine from the body by breaking it down and passing it out.

end-stage renal disease: The most advanced, permanent stage of kidney failure, usually needing dialysis or a kidney transplant.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

extrapyramidal symptoms: Movement problems caused by certain medicines, such as stiffness, tremor, restlessness, or unusually slow movements.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

G6PD deficiency: An inherited lack of an enzyme that protects red blood cells, which can cause them to break down.

galactorrhea: Milky discharge from the breasts that is not related to breastfeeding.

gastroesophageal reflux disease: Stomach acid flowing back up into the food pipe, causing heartburn and irritation.

GERD: Stomach acid flowing back up into the food pipe, causing heartburn and irritation.

gynecomastia: Swelling or enlargement of breast tissue in males.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hemodialysis: A treatment that uses a machine to filter waste and extra fluid from the blood when the kidneys cannot.

hemolytic anemia: A shortage of red blood cells caused by them breaking apart faster than the body can replace them.

hemorrhage: Bleeding, especially heavy or uncontrolled bleeding, either inside the body or from an outside wound.

hepatic impairment: Reduced liver function, meaning the liver does not work as well as normal at processing substances, including medicines.

hepatotoxicity: Damage to the liver caused by a medicine or other substance.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hyperprolactinemia: A higher-than-normal level of prolactin, a hormone, in the blood, which can affect fertility and breast milk.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypertension: Blood pressure that stays higher than normal, commonly called high blood pressure.

hypotension: Blood pressure that is lower than normal, which can cause dizziness or fainting.

in utero: Inside the womb, describing a baby before it is born.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

insomnia: Trouble falling asleep, staying asleep, or getting restful sleep.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

laryngospasm: A sudden spasm of the vocal cords that briefly closes the voice box and makes it hard to breathe or speak.

leukopenia: A low level of white blood cells, the cells that help the body fight off infections.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

methemoglobinemia: A condition where the blood carries less oxygen than normal because of a change in its oxygen-carrying protein.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

neonatal: Relating to a newborn baby during its first four weeks of life.

neuroleptic malignant syndrome: A rare but serious reaction to certain medicines causing high fever, severe muscle stiffness, confusion, and an unstable heartbeat.

neutropenia: A low level of neutrophils, a type of white blood cell that fights infection, which can make it easier to catch infections.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

perforation: A hole that forms all the way through the wall of the stomach or intestine.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

postpartum: The period of time right after a woman gives birth.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

restlessness: An inability to stay calm or still, with a constant feeling of needing to move.

serotonin syndrome: A potentially dangerous reaction from too much of the brain chemical serotonin, causing agitation, fast heartbeat, sweating, and muscle twitching.

steady state: The point where the amount of medicine going in equals the amount leaving, so blood levels stay fairly even.

stridor: A harsh, high-pitched sound heard when breathing in, caused by narrowing of the upper airway.

suicidal ideation: Thoughts about wanting to end your own life, which can range from a passing wish to a detailed plan.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

tardive dyskinesia: Involuntary, repetitive movements—often of the face, mouth, or tongue—that can develop after long-term use of certain medicines.

Tmax: The time after a dose when a medicine reaches its highest level in the blood.

tremor: Shaking or trembling of part of the body, such as the hands, that a person cannot control.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

← 43386-0580-31 · Lupin 43386-0622-30 · Lupin →

For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.

METOCLOPRAMIDE hydrochloride 5 mg Tablet, Orally Disintegrating, 10-count

🆔 Identity & classification

🏷️ RxNorm drug class

🏭 Manufacturer & labeler

🩺 Clinical

Patient education

Supplement & herbal interactions

💊 What it looks like

🧪 Inactive Ingredients / Excipients

Inactive ingredient FAQ

💲 Pricing

🔁 Therapeutic equivalents

⏳ Availability & generic status

🔬 Reported adverse events (FAERS)

Top reported reactions

Age at onset

Reporter sex

📦 Packaging — all sizes for this product

🧭 About this NDC listing & data coverage

Questions about this listing

📄 Full prescribing information FDA SPL

8 USE IN SPECIFIC POPULATIONS

8.5 Geriatric Use Metoclopramide is known to be substantially excreted b…

12 CLINICAL PHARMACOLOGY

🔗 Related NDC lookups

💊 Related drugs in this class