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Metoclopramide 5 mg/mL Injection, Solution — NDC 0703-4502-93 (Billing 00703-4502-93)

by Teva Parenteral Medicines, Inc. · 10 VIAL, SINGLE-USE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-USE

This is a package of Metoclopramide 5 mg/mL Injection, Solution from Teva Parenteral Medicines, Inc., marketed since Sep 2024 and currently FDA-listed.

NDC 00703-4502-93
🏷️ FDA NDC (as labeled) 0703-4502-93 billing pads the labeler segment with a zero
This package
Contains2 mL in 1 vial, single-use Medicaid pays$5.33 / unit · 12 mo Per package$106.62 / 20 ml · Medicaid Pack sizes2 compare ↓
Product page 00703-4502-04 Also comes in: 25 vials 0703-4502-04
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 8, 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

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

NDC database record

One package, one record: these facts belong to NDC 0703-4502-93 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0703 labeler · 4502 product · 93 package
Package marketed since
Sep 4, 2024
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 0703450293 8
Medicaid fills, this package
4,011 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026
⚠️
Other active recalls for Metoclopramide (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · May 23, 2025 — Presence of foreign tablets/capsules. (Teva Pharmaceuticals USA, Inc) · FDA recall D-0473-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
Past resolved recalls for this product (1)
Class II · Jul 29, 2021 · Terminated — Lack of Assurance of Sterility (Teva Pharmaceuticals USA) · FDA recall D-0741-2021

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0703-4502-93
Product NDC 0703-4502
11-digit billing NDC 00703450293
NCPDP billing unit ML — per mL (volume)
RxCUI 311670
UNII W1792A2RVD
Application # ANDA073135
SPL Set ID 5645a752-8868-4b51-8b59-48bb4276d763
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 2024-09-04
Route INTRAMUSCULAR, INTRAVENOUS
Dosage form INJECTION, SOLUTION
Substance METOCLOPRAMIDE HYDROCHLORIDE
TE code (Orange Book) AP · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 52300020102005
GPI class Metoclopramide HCl
GCN Seq No 005229
GCN 20510
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 10 MG/2 ML VIAL
FDB brand name Metoclopramide Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 005229
  • GCN: 20510
  • GPI-14 (Medi-Span): 52300020102005
  • HICL (First Databank): 002148
  • AHFS class code: 56:32.00.00
  • RxCUI (RxNorm): 311670
Why two NDCs? The FDA registers this code as 0703-4502-93 — a 4-4-2 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 labeler segment → 00703-4502-93. 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.

Clinical

Label name METOCLOPRAMIDE 10 MG/2 ML VIAL Ingredient Metoclopramide Hcl
📗 Our plain-language guide HelloPharmacist
  • It helps the stomach and esophagus move things along. It's used for reflux that hasn't responded to usual treatment and for diabetic gastroparesis. The injection is also used for c...
  • The oral forms and Gimoti nasal spray are generally used about 30 minutes before meals and at bedtime. Follow your prescriber's directions and the label. Don't keep taking it longe...
  • Treatment is meant to be short, generally no more than 12 weeks. The longer you take it, the higher your risk of tardive dyskinesia, a movement disorder that can be permanent.
  • Restlessness, drowsiness, tiredness and weakness are most common. Some people have nausea, diarrhea, headache or dizziness. Be careful driving until you know how it affects you.
📖 Read our full Metoclopramide guide →
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.

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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo $5.33 $106.62 / 20 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2765 $1.004 / J2765 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)0703-4502-93
11-digit billing NDC00703-4502-93
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ2765
DescriptorINJECTION, METOCLOPRAMIDE HCL, UP TO 10 MG
Billing units / pkg0.5 units
How the units are derivedThis package is 2 ML; the HCPCS unit is 10 MG, so one package = 0.5 billing units.
Medicare Part B spend (2026 (Q1))$769 · 585 claims · $1.31 per claim (all NDCs under J2765)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00703-4502-04 0703-4502-04 Main listing 25 VIAL, SINGLE-USE in 1 TRAY / 2 mL in 1 VIAL, SINGLE-USE $0.5290 / mL $26.45 1991-12-01 — Active
00703-4502-93 You're viewing this 10 VIAL, SINGLE-USE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-USE — — 2024-09-04 — Active

This pack accounts for about 19% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 10 vial, single-use in 1 carton / 2 ml in 1 vial, single-use.
What NDC number is used to bill for this package of Metoclopramide 5 mg/mL Injection, Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Metoclopramide 5 mg/mL 00409-3414-01 Hospira, 25 vials $0.529 AP Discontinued —
Metoclopramide 5 mg/mL 00409-5255-25 Hospira, 25 vials $0.529 AP Discontinued —
Metoclopramide 5 mg/mL 23155-0240-41 Heritage 25 vials $0.529 AP Availability likely —
Metoclopramide 5 mg/mL 83634-0779-02 Avenacy, 25 vials $0.529 AP Availability likely —
Metoclopramide 5 mg/mL 00404-9771-02 Henry 1 vial — AP FDA listed —
Metoclopramide 5 mg/mLthis 00703-4502-93 Teva 10 vials — AP FDA listed —
Metoclopramide 5 mg/mL 51662-1288-01 HF 2 ml — AP FDA listed —
Metoclopramide 5 mg/mL 51662-1670-03 HF 25 pouches — AP FDA listed —
Metoclopramide 5 mg/mL 55154-0450-05 Cardinal 5 vials — AP FDA listed —
Metoclopramide 5 mg/mL 55154-2353-05 Cardinal 5 vials — AP FDA listed —
Metoclopramide 5 mg/mL 55154-7832-05 Cardinal 5 vials — AP FDA listed —
Metoclopramide 5 mg/mL 71872-7076-01 Medical 1 vial — AP FDA listed —
Metoclopramide 5 mg/mL 71872-7265-01 Medical 1 vial — AP FDA listed —
Metoclopramide 5 mg/mL 71872-7346-01 Medical 1 vial — AP FDA listed —
Metoclopramide 5 mg/mL 84549-0414-11 ProPharma 2 ml — AP FDA listed —
Metoclopramide 5 mg/mL 36000-0366-25 Baxter 25 vials — — 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

🏛️
2024
On the market since
Sep 2024
📍
2026
Currently FDA-listed
2 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.

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.

🧪 Avoiding an ingredient? See Metoclopramide inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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.

Manufacturer & labeler

LabelerTeva Parenteral Medicines, Inc.
Application holderTEVA PHARMACEUTICALS USA
FDA applicationANDA073135 (ANDA)
Labeler code00703
First marketedSep 2024
Product typeHuman Prescription Drug
Portfolio28 products on file

More NDCs from Teva Parenteral Medicines, Inc. labeler code 00703

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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide ⚠️ Precautions 🍼 Nursing Mothers 🧬 Pharmacokinetics 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Package Label / Principal Display Panel
🚨 Boxed Warning 103 words ▾

WARNING: TARDIVE DYSKINESIA Metoclopramide, including metoclopramide injection, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. In patients treated with metoclopramide, including metoclopramide injection, the risk of developing tardive dyskinesia increases with duration of treatment and total cumulative dosage. Metoclopramide injection is contraindicated in patients with a history of TD.

Immediately discontinue metoclopramide injection in patients who develop signs or symptoms of TD. In patients with diabetic gastroparesis, avoid a total duration of treatment with metoclopramide products, including metoclopramide injection, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD.

See WARNINGS .

🎯 Indications and Usage 139 words ▾

INDICATIONS AND USAGE Diabetic Gastroparesis Metoclopramide injection is indicated for the relief of symptoms associated with acute and recurrent diabetic gastroparesis is in adults. The Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy Metoclopramide injection is indicated for the prophylaxis of vomiting associated with emetogenic cancer chemotherapy in adults. The Prevention of Postoperative Nausea and Vomiting Metoclopramide injection is indicated for the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable in adults.

Small Bowel Intubation Metoclopramide injection is indicated to facilitate small bowel intubation in adult and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers. Radiological Examination Metoclopramide injection is indicated to stimulate gastric emptying and intestinal transit of barium where delayed emptying interferes with radiological examination of the stomach and/or small intestine in adults.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION For the Relief of Symptoms Associated with Diabetic Gastroparesis If only the earliest manifestations of diabetic gastroparesis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, the recommended dosage of metoclopramide injection in adults is 10 mg administered intramuscularly or intravenously over at least 1- to 2-minutes. Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration of metoclopramide may be instituted.

Avoid a total duration of treatment with metoclopramide products, including metoclopramide injection, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD (see WARNINGS – Tardive Dyskinesia ). For the Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy The recommended dosage of metoclopramide injection in adults is 2 mg/kg, with highly emetogenic drugs (e.g., cisplatin or dacarbazine) alone or in combination, and 1 mg/kg, with less emetogenic drugs, infused intravenously over at least 15 minutes, 30 minutes before beginning cancer chemotherapy and repeated every 2 hours for two doses, then every 3 hours for three doses.

For doses in excess of 10 mg, metoclopramide injection should be diluted in 50 mL of a parenteral solution. The preferred parenteral solution is Sodium Chloride Injection (normal saline), which when combined with metoclopramide injection, can be stored frozen for up to 4 weeks. Metoclopramide injection is degraded when admixed and frozen with Dextrose-5% in Water.

Metoclopramide injection diluted in Sodium Chloride Injection, Dextrose-5% in Water, Dextrose-5% in 0.45% Sodium Chloride, Ringer’s Injection, or Lactated Ringer’s Injection may be stored up to 48 hours (without freezing) after preparation if protected from light. All dilutions may be stored unprotected from light under normal light conditions up to 24 hours after preparation. If acute dystonic reactions should occur, inject 50 mg Benadryl ® (diphenhydramine hydrochloride) intramuscularly, and the symptoms usually will subside.

For the Prevention of Postoperative Nausea and Vomiting The recommended dosage of metoclopramide injection in adults is 10 mg or 20 mg as a single intramuscular injection near the end of surgery. To Facilitate Small Bowel Intubation In adult and pediatric patients undergoing small bowel intubation, in whom the tube has not passed the pylorus with conventional maneuvers after 10 minutes, the recommended dosage of metoclopramide injection is a single dose administered (undiluted) by the intravenous route over at least 1 to 2 minutes: Adults and pediatric patients above 14 years of age: 10 mg Pediatric patients 6 to 14 years of age: 2.5 to 5 mg Pediatric patients less than 6 years of age: 0.1 mg/kg To Aid in Radiological Examinations In adult patients where delayed gastric emptying interferes with radiological examination of the stomach and/or small intestine, the recommended dosage of metoclopramide injection is a single 10 mg dose administered (undiluted) by the intravenous route over at least 1- to 2-minutes.

Use in Patients with Renal Impairment The clearance of metoclopramide is decreased, and the systemic exposure is increased in patients with moderate to severe renal impairment compared to patients with normal renal function, which may increase the risk of adverse reactions. There is no dosage adjustment for patients with mild renal impairment (creatinine clearance greater than 60 mL/minute). For patients with moderate or severe renal impairment (creatinine clearance less than or equal to 60 mL/minute), who are receiving more than a single dose of metoclopramide injection, reduce the metoclopramide injection dosage to one-half the dosage recommended for patients with normal renal function.

For patients with End-Stage Renal Disease (ESRD) including those treated with hemodi… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 88 words ▾

CONTRAINDICATIONS Metoclopramide injection is contraindicated: in patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide. See WARNINGS . whenever 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. Metoclopramide may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor. in patients with known sensitivity or intolerance to metoclopramide. in patients with epilepsy.

Metoclopramide injection may increase the frequency and severity of seizures.

⚠️ Warnings ~3 min read ▾

WARNINGS Tardive Dyskinesia (see BOXED WARNING) Metoclopramide, including metoclopramide injection, can cause tardive dyskinesia (TD), a syndrome of potentially irreversible and disfiguring involuntary movements of the face or tongue, and sometimes of the trunk and/or extremities. Metoclopramide, including metoclopramide injection, may also suppress, or partially suppress, the signs of TD, and may delay the diagnosis of TD because it may mask the underlying disease process. The effect of the symptomatic suppression upon the long-term course of TD is unknown.

TD may remit, partially or completely, if treatment with metoclopramide injection is discontinued. In patients treated with metoclopramide, including metoclopramide injection, the risk of developing TD and the likelihood that TD will become irreversible increases with duration of treatment and total cumulative dosage. Additionally, the risk of developing TD is increased in elderly patients, especially in elderly women, and in patients with diabetes mellitus.

Prevention, Mitigation, and Monitoring for TD Metoclopramide injection, contraindicated in patients with history of TD Avoid use of metoclopramide injection in patients receiving concomitant antipsychotics due to the potential additive effects of TD. Reduce the dosage of metoclopramide injection in the elderly. (see DOSAGE AND ADMINISTRATION , Renal and Hepatic Impairment ).

Immediately discontinue metoclopramide injection immediately in patients who develop signs and symptoms of TD. In patients with diabetic gastroparesis, avoid a total duration of treatment with metoclopramide products, including metoclopramide injection, for longer than 12 weeks. If longer-term use is unavoidable, routinely monitor for signs and symptoms of TD.

If patients have continued TD symptoms, consider TD treatment. Other 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 injection.

Extrapyramidal symptoms (EPS), such as acute dystonic reactions, occurred in patients treated with metoclopramide dosages of 30 mg to 40 mg daily. Such reactions occurred more frequently in adults less than 30 years of age and at the higher dosages used in prophylaxis of vomiting due to cancer chemotherapy. EPS occurred more frequently in pediatric patients compared to adults (metoclopramide injection is only approved in pediatric patients for small bowel intubation).

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 injection in patients receiving other drugs that can cause EPS (e.g., antipsychotics). Parkinsonian 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 within 2 to 3 months after discontinuation of metoclopramide. Avoid metoclopramide injection in patients with Parkinson’s disease and other patients being treated with antiparkinsonian drugs due to potential exacerbation of symptoms. If treatment is unavoidable, use metoclopramide injection for the shortest duration of treatment and periodically reassess the need for continued treatment.

Routinely monitor for signs and symptoms of Parkinson’s disease. Motor restlessness (akathisia) has developed and consisted of feelings of anxiety, agitation, jitteriness, and insomnia, as well as inabilit… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS In general, the incidence of adverse reactions correlates with the dose and duration of metoclopramide administration. The following reactions have been reported, although in most instances, data do not permit an estimate of frequency. CNS Effects Restlessness, drowsiness, fatigue, and lassitude may occur in patients receiving the recommended prescribed dosage of metoclopramide injection.

Insomnia, headache, confusion, dizziness, or mental depression with suicidal ideation also may occur (see WARNINGS ). In cancer chemotherapy patients being treated with 1 to 2 mg/kg per dose, incidence of drowsiness is about 70%. There are isolated reports of convulsive seizures without clear-cut relationship to metoclopramide.

Rarely, hallucinations have been reported. Extrapyramidal Reactions (EPS) Acute dystonic reactions, the most common type of EPS associated with metoclopramide, occur in approximately 0.2% of patients (1 in 500) treated with 30 to 40 mg of metoclopramide per day. In cancer chemotherapy patients receiving 1 to 2 mg/kg per dose, the incidence is 2% in patients over the ages of 30 to 35, and 25% or higher in pediatric patients and adult patients less than 30 years of age who have not had prophylactic administration of diphenhydramine.

Symptoms include involuntary movements of limbs, facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, opisthotonus (tetanus-like reactions), and, rarely, stridor and dyspnea possibly due to laryngospasm; ordinarily these symptoms are readily reversed by diphenhydramine (see WARNINGS ). Parkinsonian-like symptoms may include bradykinesia, tremor, cogwheel rigidity, mask-like facies (see WARNINGS ). Tardive dyskinesia most frequently is characterized by involuntary movements of the tongue, face, mouth, or jaw, and sometimes by involuntary movements of the trunk and/or extremities; movements may be choreoathetotic in appearance (see WARNINGS ).

Motor restlessness (akathisia) may consist of feelings of anxiety, agitation, jitteriness, and insomnia, as well as inability to sit still, pacing, foot tapping. These symptoms may disappear spontaneously or respond to a reduction in dosage. Neuroleptic Malignant Syndrome Rare occurrences of neuroleptic malignant syndrome (NMS) have been reported.

This potentially fatal syndrome is comprised of the symptom complex of hyperthermia, muscular rigidity, altered consciousness, and autonomic instability (see WARNINGS ). Endocrine Disturbances Galactorrhea, amenorrhea, gynecomastia, impotence secondary to hyperprolactinemia (see PRECAUTIONS ). Fluid retention secondary to transient elevation of aldosterone (see CLINICAL PHARMACOLOGY ).

Cardiovascular Hypotension, hypertension, supraventricular tachycardia, bradycardia, fluid retention, acute congestive heart failure and possible atrioventricular (AV) block (see CONTRAINDICATIONS and PRECAUTIONS ). Gastrointestinal Nausea and bowel disturbances, primarily diarrhea. Hepatic Rarely, cases of hepatotoxicity, characterized by such findings as jaundice and altered liver function tests, when metoclopramide was administered with other drugs with known hepatotoxic potential.

Renal Urinary frequency and incontinence. Hematologic A few cases of neutropenia, leukopenia, or agranulocytosis, generally without clear-cut relationship to metoclopramide. Methemoglobinemia in adults and especially with overdosage in neonates (see OVERDOSAGE ).

Sulfhemoglobinemia in adults. Allergic Reactions A few cases of rash, urticaria, or bronchospasm, especially in patients with a history of asthma. Rarely, angioneurotic edema, including glossal or laryngeal edema.

Miscellaneous Visual disturbances. Porphyria. Transient flushing of the face and upper body, without alterations in vital signs, following high doses intravenously.

🔄 Drug Interactions 65 words ▾

Adverse Reactions with Rapid Intravenous Administration Intravenous injections of undiluted metoclopramide injection should be made slowly allowing 1 to 2 minutes for 10 mg since a transient but intense feeling of anxiety and restlessness, followed by drowsiness, may occur with rapid administration. Intravenous administration of metoclopramide injection diluted in a parenteral solution should be made slowly over a period of not less than 15 minutes.

🤰 Pregnancy 74 words ▾

Effects on the Ability to Drive and Operate Machinery Metoclopramide may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. Concomitant use of central nervous system (CNS) depressants or drugs associated with EPS may increase this effect (e.g., alcohol, sedatives, hypnotics, opiates, and anxiolytics). Avoid metoclopramide injection or the interacting drug, depending on the importance of the drug to the patient.

🧒 Pediatric Use ~1 min read ▾

Information for Patients A patient Medication Guide is available for metoclopramide injection. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have.

Refer to accompanying Medication Guide. Tardive Dyskinesia and/or other Extrapyramidal Reactions Metoclopramide injection may cause tardive dyskinesia or other extrapyramidal symptoms, parkinsonian symptoms, and motor restlessness. Instruct patients to immediately contact their healthcare provider if symptoms occur.

See WARNINGS . Neuroleptic Malignant Syndrome Serious neuroleptic malignant syndrome (NMS) has been reported in association with concomitant treatment of metoclopramide with another drug associated with NMS. Advise patients to report all prescription and over-the-counter medications to the healthcare provider.

Instruct patients to seek medical attention if symptoms occur. Depression and/or Possible Suicidal Ideation Symptoms of new onset or worsening depression as well as suicidal ideation have been reported in patients taking metoclopramide. Instruct patients to contact their healthcare provider if any of these symptoms occur.

Drug Interactions 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. Advise patients to report all prescriptions and over the counter medications to the healthcare provider. Effects on the Ability to Drive and Operate Machinery Metoclopramide 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.

🧓 Geriatric Use 164 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility A 77-week study was conducted in rats with oral doses up to about 40 times the maximum recommended human daily dose. Metoclopramide elevates prolactin levels and the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin-dependent in vitro , a factor of potential importance if the prescription of metoclopramide is contemplated in a patient with previously detected breast cancer.

Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported with prolactin-elevating drugs, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of prolactin-stimulating neuroleptic drugs and metoclopramide. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is too limited to be conclusive at this time.

An Ames mutagenicity test performed on metoclopramide was negative.

🆘 Overdosage 118 words ▾

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 ). There are no specific antidotes for metoclopramide injection 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 glucose-6-phosphate dehydrogenase (G6PD) deficiency, which may be fatal.

Hemodialysis and continuous ambulatory peritoneal dialysis do not remove significant amounts of metoclopramide.

🧬 Clinical Pharmacology ~3 min read ▾

CLINICAL PHARMACOLOGY Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. Its mode of action is unclear. 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. In patients with gastroesophageal reflux and low LESP (lower esophageal sphincter pressure), single oral doses of metoclopramide produce dose-related increases in LESP. Effects begin at about 5 mg and increase through 20 mg (the largest dose tested).

The increase in LESP from a 5 mg dose lasts about 45 minutes and that of 20 mg lasts between 2 and 3 hours. Increased rate of stomach emptying has been observed with single oral doses of 10 mg. The antiemetic properties of metoclopramide appear to be a result of its antagonism of central and peripheral dopamine receptors.

Dopamine produces nausea and vomiting by stimulation of the medullary chemoreceptor trigger zone (CTZ), and metoclopramide blocks stimulation of the CTZ by agents like l-dopa or apomorphine which are known to increase dopamine levels or to possess dopamine-like effects. Metoclopramide also abolishes the slowing of gastric emptying caused by apomorphine. Like the phenothiazines and related drugs, which are also dopamine antagonists, metoclopramide produces sedation and may produce extrapyramidal reactions, although these are comparatively rare (see WARNINGS ).

Metoclopramide inhibits the central and peripheral effects of apomorphine, induces release of prolactin and causes a transient increase in circulating aldosterone levels, which may be associated with transient fluid retention. The onset of pharmacological action of metoclopramide is 1 to 3 minutes following an intravenous dose, 10 to 15 minutes following intramuscular administration, and 30 to 60 minutes following an oral dose; pharmacological effects persist for 1 to 2 hours. Pharmacokinetics Metoclopramide is rapidly and well absorbed.

Relative to an intravenous dose of 20 mg, the absolute oral bioavailability of metoclopramide is 80% ± 15.5% as demonstrated in a crossover study of 18 subjects. Peak plasma concentrations occur at about 1 to 2 hr 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, the area under the drug concentration-time curve increases linearly with doses from 20 to 100 mg. Peak concentrations increase linearly with dose; time to peak concentrations remains the same; whole body clearance is unchanged; and the elimination rate remains the same. The average elimination half-life in individuals with normal renal function is 5 to 6 hr.

Linear kinetic processes adequately describe the absorption and elimination of metoclopramide. Approximately 85% of the radioactivity of an orally administered dose appears in the urine within 72 hr. Of the 85% eliminated in the urine, about half is present as free or conjugated metoclopramide.

The drug is not extensively bound to plasma proteins (about 30%). The whole body volume of distribution is high (about

3.5L/kg) which suggests extensive distribution of drug to the tissues (see Table 1). Table 1. Adult Pharmacokinetic Data Parameter Value Vd (L/kg) ~

3.5Plasma Protein Binding ~ 30% t 1/2 (hr) 5 to 6 Oral Bioavailability 80%±15.5% Patients with Renal Impairment In a study of 24 patients with varying degrees of renal impairment (moderate, severe, and end-stage renal disease (ESRD) requiring… [Excerpted — this section continues on DailyMed.]

📦 How Supplied / Storage and Handling 146 words ▾

HOW SUPPLIED Metoclopramide injection, USP is supplied in 2 mL single-dose vials packaged 10 per shelf pack. NDC Number Metoclopramide Injection, USP Volume 0703-4502-93 5 mg/mL 2 mL in a 2 mL single-dose vial PROTECT FROM LIGHT. Store in shelf pack until time of use.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Inspect the vial before use and discard if either color or particulate is observed. Dilutions may be stored unprotected from light under normal light conditions for up to 24 hours after preparation.

Do not freeze. Do not store open single-dose vials for later use, as they contain no preservative. Discard unused portion.

To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured In Croatia By: Pliva Hrvatska d.o.o. Zagreb, Croatia Novaplus is a registered trademark of Vizient, Inc.

Rev. B 4/2026 1

📋 Description 127 words ▾

DESCRIPTION Metoclopramide hydrochloride, USP is a white crystalline, odorless substance, freely soluble in water. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate and has the following structural formula: C 14 H 22 ClN 3 O 2 •HCl•H 2 O M.W. 354.3 Metoclopramide injection, USP is a clear, colorless, sterile solution with a pH of 2.5 to 6.5 for intravenous (IV) or intramuscular (IM) administration.

This product is light sensitive. It should be inspected before use and discarded if either color or particulate is observed. Metoclopramide injection, USP is supplied in 2 mL single-dose vials.

Each 1 mL contains: Metoclopramide base 5 mg (present as the hydrochloride), Sodium Chloride, USP 8.5 mg, Water for Injection, USP q.s. pH is adjusted with hydrochloric acid and/or sodium hydroxide if necessary. 1

💬 Information for Patients 42 words ▾

Fluid Overload Because metoclopramide produces a transient increase in plasma aldosterone, certain patients, especially those with cirrhosis or congestive heart failure, may be at risk of developing fluid retention and volume overload. Discontinue metoclopramide injection if any of these adverse reactions occur.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Metoclopramide (met” oh kloe’ pra mide) Injection You or your caregiver should read the Medication Guide before you start receiving metoclopramide injection and before you get another dose of metoclopramide injection. There may be new information. If you take another product that contains metoclopramide (such as tablets, orally disintegrating tablets, oral syrup, or nasal spray), 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 to your doctor about your medical condition or your treatment. What is the most important information I should know about metoclopramide injection?

Metoclopramide injection can cause serious side effects, including: Tardive Dyskinesia: Metoclopramide, including metoclopramide injection, can cause tardive dyskinesia (TD), a potentially irreversible serious movement disorder. These movements happen mostly in the face or tongue, and sometimes in the arms or legs. You cannot control these movements.

These symptoms may not go away even after stopping metoclopramide injection. Your chances for getting TD go up: the longer you take metoclopramide injection and the more metoclopramide injection you take. People taking metoclopramide injection to relieve the symptoms of slow stomach emptying due to diabetes, should not take metoclopramide injection, or other drugs containing metoclopramide, for more than 12 weeks. if you are older, especially if you are a woman. if you have diabetes It is not possible for your doctor to know if you will get TD if you take metoclopramide injection.

Call your doctor right away if you get movements you can not stop or control, such as: lip smacking, chewing, or puckering up your mouth frowning or scowling sticking out your tongue blinking and moving your eyes shaking of your arms and legs Your doctor may stop treatment with metoclopramide injection if you develop signs or symptoms of TD. See the section “What are the possible side effects of metoclopramide injection?” for more information about side effects. What is metoclopramide injection?

Metoclopramide injection is a prescription medicine used to: relieve symptoms of slow stomach emptying in adults with diabetes. prevent nausea and vomiting that can happen with cancer chemotherapy in adults. prevent nausea and vomiting that may happen after surgery in adults, if your doctor decides that you should not be treated with a stomach tube and suction. help make it easier to insert a tube into the small intestine in both adults and children, if the tube does not pass into the stomach normally. to help empty stomach contents or to help barium move through the intestine in adults, when you get an X-ray examination of the stomach or small intestine.

It is not known if metoclopramide is safe and effective in children except when used to help insert a tube into the small intestine. Who should not receive metoclopramide injection? Do not receive metoclopramide injection if you: have a history of tardive dyskinesia or have a problem controlling your muscles and movements after taking metoclopramide injection or a medicine that works like metoclopramide injection. have stomach or intestine problems that could get worse with metoclopramide injection, such as bleeding, blockage or a tear in your stomach or bowel wall. have an adrenal gland tumor called pheochromocytoma. are allergic to metoclopramide. have seizures.

What should I tell my doctor before receiving metoclopramide injection? Tell your doctor about all of your medical conditions, including if you: have problems controlling your muscle movements after taking any medicine. have Parkinson’s disease. have or had depression or mental illness. have kidney or liver problems. have heart failure or heart rhythm problems. have high blood pressure. drink alcohol. have diabetes. Your dose of insulin may need to be changed. are pregnant or plan to become pregnant.

I… [Excerpted — this section continues on DailyMed.]

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Hypertension In one study in hypertensive patients, intravenously administered metoclopramide was shown to release catecholamines; avoid metoclopramide injection in patients with hypertension or patients taking monoamine oxidase inhibitors (see PRECAUTIONS – Drug Interactions ). There are also clinical reports of hypertensive crises in patients with undiagnosed pheochromocytoma. Metoclopramide injection is contraindicated in patients with pheochromocytoma or other catecholamine-releasing paragangliomas.

Discontinue metoclopramide injection in any patient with a rapid rise in blood pressure. Fluid Overload Because metoclopramide produces a transient increase in plasma aldosterone, certain patients, especially those with cirrhosis or congestive heart failure, may be at risk of developing fluid retention and volume overload. Discontinue metoclopramide injection if any of these adverse reactions occur.

Adverse Reactions with Rapid Intravenous Administration Intravenous injections of undiluted metoclopramide injection should be made slowly allowing 1 to 2 minutes for 10 mg since a transient but intense feeling of anxiety and restlessness, followed by drowsiness, may occur with rapid administration. Intravenous administration of metoclopramide injection diluted in a parenteral solution should be made slowly over a period of not less than 15 minutes. Anastamotic Dehiscence Giving a promotility drug such as metoclopramide theoretically could put increased pressure on suture lines following a gut anastomosis or closure.

This possibility should be considered and weighed when deciding whether to use metoclopramide injection or nasogastric suction in the prevention of postoperative nausea and vomiting. Effects on the Ability to Drive and Operate Machinery Metoclopramide may impair the mental and/or physical abilities required for the performance of hazardous tasks such as operating machinery or driving a motor vehicle. Concomitant use of central nervous system (CNS) depressants or drugs associated with EPS may increase this effect (e.g., alcohol, sedatives, hypnotics, opiates, and anxiolytics).

Avoid metoclopramide injection or the interacting drug, depending on the importance of the drug to the patient. Drug Interactions Effects of Other Drugs on Metoclopramide Table 3 displays the effects of other drugs on metoclopramide. Table 3.

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 . Strong CYP2D6 Inhibitors, not Included in Antipsychotic Category Above Clinical Impact Increased plasma concentrations of metoclopramide; risk of exacerbation of extrapyramidal symptoms.

Intervention Avoid metoclopramide injection. If use is unavoidable, monitor for adverse reactions Examples quinidine, bupropion, fluoxetine, and paroxetine Monoamine Oxidase Inhibitors Clinical Impact Increased risk of hypertension . Intervention Avoid concomitant use.

Central Nervous System (CNS) Depressants Clinical Impact Increased risk of CNS depression . Intervention Avoid metoclopramide injection 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 due to opposing effects on dopamine. Intervention Monitor for reduced therapeutic effect. Examples apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine Effects of Metoclopramide… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers ~2 min read ▾

Drug Interactions Effects of Other Drugs on Metoclopramide Table 3 displays the effects of other drugs on metoclopramide. Table 3. 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 . Strong CYP2D6 Inhibitors, not Included in Antipsychotic Category Above Clinical Impact Increased plasma concentrations of metoclopramide; risk of exacerbation of extrapyramidal symptoms. Intervention Avoid metoclopramide injection.

If use is unavoidable, monitor for adverse reactions Examples quinidine, bupropion, fluoxetine, and paroxetine Monoamine Oxidase Inhibitors Clinical Impact Increased risk of hypertension . Intervention Avoid concomitant use. Central Nervous System (CNS) Depressants Clinical Impact Increased risk of CNS depression .

Intervention Avoid metoclopramide injection 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 due to opposing effects on dopamine.

Intervention Monitor for reduced therapeutic effect. Examples apomorphine, bromocriptine, cabergoline, levodopa, pramipexole, ropinirole, and rotigotine Effects of Metoclopramide on Other Drugs Table 4 displays the effects of metoclopramide on other drugs. Table 4.

Effects of Metoclopramide on Other Drugs Dopaminergic Agonists and Drugs Increasing 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.

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 the interacting drug. Insulin Clinical Impact Increased GI motility by metoclopramide may increase delivery of food to the intestines and increase blood glucose. Intervention Monitor blood glucose and adjust insulin dosage regimen as needed. * Interaction does not apply to posaconazole delayed-release tablets

🧬 Pharmacokinetics ~2 min read ▾

Pharmacokinetics Metoclopramide is rapidly and well absorbed. Relative to an intravenous dose of 20 mg, the absolute oral bioavailability of metoclopramide is 80% ± 15.5% as demonstrated in a crossover study of 18 subjects. Peak plasma concentrations occur at about 1 to 2 hr 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, the area under the drug concentration-time curve increases linearly with doses from 20 to 100 mg. Peak concentrations increase linearly with dose; time to peak concentrations remains the same; whole body clearance is unchanged; and the elimination rate remains the same.

The average elimination half-life in individuals with normal renal function is 5 to 6 hr. Linear kinetic processes adequately describe the absorption and elimination of metoclopramide. Approximately 85% of the radioactivity of an orally administered dose appears in the urine within 72 hr.

Of the 85% eliminated in the urine, about half is present as free or conjugated metoclopramide. The drug is not extensively bound to plasma proteins (about 30%). The whole body volume of distribution is high (about

3.5L/kg) which suggests extensive distribution of drug to the tissues (see Table 1). Table 1. Adult Pharmacokinetic Data Parameter Value Vd (L/kg) ~

3.5Plasma Protein Binding ~ 30% t 1/2 (hr) 5 to 6 Oral Bioavailability 80%±15.5% Patients with Renal Impairment In a study of 24 patients with varying degrees of renal impairment (moderate, severe, and end-stage renal disease (ESRD) requiring dialysis), the systemic exposure (AUC) of metoclopramide following intravenous administration in patients with moderate to severe renal impairment was about 2-fold the AUC in subjects with normal renal function. The AUC of metoclopramide in patients with ESRD in dialysis was about 3.5-fold the AUC in subjects with normal renal function.

Patients with Hepatic Impairment In a group of 8 patients with severe hepatic impairment (Child-Pugh C) administered intravenous metoclopramide, the average metoclopramide clearance was reduced by approximately 50% compared to patients with normal hepatic function. Effect of CYP2D6 Inhibitors on Metoclopramide In healthy subjects, 20 mg of oral metoclopramide and 60 mg of fluoxetine (a strong CYP2D6 inhibitor) were administered, following prior exposure to 60 mg fluoxetine orally for 8 days. The patients who received concomitant metoclopramide and fluoxetine had a 40% and 90% increase in metoclopramide C max and AUC 0-∞, respectively, compared to patients who received metoclopramide alone (see Table 2).

Table 2. Oral Metoclopramide Pharmacokinetic Parameters in Healthy Subjects with and without Fluoxetine Parameter Metoclopramide alone (mean ±SD) Metoclopramide with fluoxetine (mean ±SD) C max (ng/mL) 44±15 62.7±9.2 AUC 0-∞ (ng∙h/mL) 313±113 591±140 T 1/2 (h) 5.5±1.1 8.5±2.2 Pediatric Patients In pediatric patients, the pharmacodynamics of metoclopramide following oral and intravenous administration are highly variable and a concentration-effect relationship has not been established. There are insufficient reliable data to conclude whether the pharmacokinetics of metoclopramide in adults and the pediatric population are similar.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 48 words ▾

Anastamotic Dehiscence Giving a promotility drug such as metoclopramide theoretically could put increased pressure on suture lines following a gut anastomosis or closure. This possibility should be considered and weighed when deciding whether to use metoclopramide injection or nasogastric suction in the prevention of postoperative nausea and vomiting.

📄 Package Label / Principal Display Panel 41 words ▾

Package/Label Display Panel NDC 0703-4502-93 Metoclopramide Injection, USP 10 mg/2 mL (5 mg/mL) of metoclopramide present as the hydrochloride For Intramuscular or Intravenous Use Dispense the accompanying Medication Guide to each patient. Rx only 10 x 2 mL Single-Dose Vials 1

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
4K
Units reimbursed last 4 qtrs
9.8K
Gross reimbursed last 4 qtrs
$52.3K
Avg / prescription
$13.05
Avg / unit
$5.3308
Latest quarter Q1 2026
1.1KRx
Fee-for-service vs managed care ⓘ
17% FFS 83% MCO
Fee-for-service · 680 Rx Managed care · 3,331 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 148 units · 2.6 per 100k residents MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 120 units · 0.6 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 4,922 units · 41.8 per 100k residents OH Pennsylvania: 486 units · 3.7 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 2,802 units · 7.2 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 156 units · 1.8 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 86 units · 2.9 per 100k residents KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 782 units · 7.2 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 294 units · 2.7 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: no data reported TX Florida: 22 units · 0.1 per 100k residents FL
Units reimbursed · per 100k residents
0.141.8
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Ohio 41.8 /100k
2 North Carolina 7.2 /100k
3 California 7.2 /100k
4 Pennsylvania 3.7 /100k
5 Kansas 2.9 /100k
6 Georgia 2.7 /100k
7 Minnesota 2.6 /100k
8 Virginia 1.8 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
25 vials00703-4502-04 16,918 Rx · $743,391
10 vials this page00703-4502-93 4,011 Rx · $52,338
Drug total (last 4 qtrs): 20,929 Rx · 58,562 units · $795,729 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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 ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) ✓ Available
“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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Teva Parenteral Medicines, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 25 vials (00703-4502-04). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Teva Parenteral Medicines, 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2765 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 00703-4248-91 · Teva 00703-5747-11 · Teva →
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.