Medicine
Metoclopramide 5 mg/5 mL oral solution
Metoclopramide 5 mg/5 mL oral solution is a generic prescription medicine for oral use, made by 8 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Protect from freezing. Store at controlled room temperature, between 20°C and…
Key facts
- Active ingredient (INN)
- Metoclopramide
- Brand
- Sold under the generic name
- Strength
- 5 mg/5 mL
- Dosage form
- Oral solution
- Route
- Oral
- Packs
- 473 mL, 10 trays, 2 trays and 17 more
- Manufacturers
- Atlantic BiologicalsBryant Ranch PrepackChartwell RXPAI PharmaAmerican Health PackagingANI PharmaceuticalsChartwell Governmental & Specialty RXGenus Lifesciences
- Origin register
- US FDA, United States
- Storage
- Protect from freezing. Store at controlled room temperature, between 20°C and 25°C (68° to 77°F).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- A03FA01 Metoclopramide
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 June 1991
- Identifiers
- RxCUI 104884DailyMed set ID 3ce3245f-7021-5135-e063-6394a90a7d95, 4e12e98a-06fe-4b3c-bb64-f2701e195c74, c4ab34f2-25e6-47bd-9dde-1f4baf469f0d +10NDC 17856-1190, 62559-190, 68999-526 +11Application ANDA071402, ANDA073680, ANDA072744
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
Packs from every labeler of this generic presentation.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 473 mL in 1 bottle | 0121-0576-16 | PAI Pharma | 1 June 1991 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 0121-1576-10 | PAI Pharma | 1 June 1991 |
| 473 mL in 1 bottle, plastic | 62559-190-16 | ANI Pharmaceuticals | 18 May 2015 |
| 2 tray in 1 box / 10 cup in 1 tray / 10 mL in 1 cup | 68999-526-24 | Chartwell Governmental & Specialty RX | 29 October 2025 |
| 2 tray in 1 box / 10 cup in 1 tray / 10 mL in 1 cup | 62135-526-24 | Chartwell RX | 14 October 2024 |
| 473 mL in 1 bottle | 62135-526-47 | Chartwell RX | 21 March 2023 |
| 473 mL in 1 bottle, plastic | 64950-344-16 | Genus Lifesciences | 1 June 2024 |
| 473 mL in 1 bottle | 63629-1961-1 | Bryant Ranch Prepack | 4 February 2021 |
| 473 mL in 1 bottle | 63629-2144-1 | Bryant Ranch Prepack | 8 February 2021 |
| 473 mL in 1 bottle, plastic | 71335-2732-1 | Bryant Ranch Prepack | 29 July 2025 |
| 473 mL in 1 bottle | 71335-2997-1 | Bryant Ranch Prepack | 5 November 2025 |
| 473 mL in 1 bottle, plastic | 72162-1750-2 | Bryant Ranch Prepack | 6 October 2023 |
| 473 mL in 1 bottle, plastic | 72162-1750-4 | Bryant Ranch Prepack | 6 October 2023 |
| 72 cup, unit-dose in 1 case / 5 mL in 1 cup, unit-dose | 17856-1190-1 | Atlantic Biologicals | 21 August 2025 |
| 120 syringe in 1 case / 1 mL in 1 syringe | 17856-1190-2 | Atlantic Biologicals | 21 August 2025 |
| 72 cup, unit-dose in 1 box, unit-dose / 10 mL in 1 cup, unit-dose | 17856-1190-3 | Atlantic Biologicals | 15 October 2026 |
| 110 syringe in 1 box, unit-dose / 1 mL in 1 syringe | 17856-1190-4 | Atlantic Biologicals | 15 October 2026 |
| 110 syringe in 1 box, unit-dose / 1 mL in 1 syringe | 17856-1190-5 | Atlantic Biologicals | 15 October 2026 |
| 60 syringe in 1 box, unit-dose / .5 mL in 1 syringe | 17856-1190-6 | Atlantic Biologicals | 15 October 2026 |
| 10 tray in 1 case / 10 cup, unit-dose in 1 tray / 10 mL in 1 cup, unit-dose | 60687-837-56 | American Health Packaging | 12 November 2024 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 7 February 1979 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Other strengths and forms of Metoclopramide
Clinical summary
Metoclopramide is a dopamine-2 receptor antagonist indicated for the treatment for 4 to 12 weeks of symptomatic, documented gastroesophageal reflux in adults who fail to respond to conventional therapy, among other approved uses. MedsAcross supplies Metoclopramide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about MetoclopramideFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Metoclopramide prescribing information (ANI Pharmaceuticals) · U.S. National Library of Medicine, DailyMed
Need Metoclopramide 5 mg/5 mL oral solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.