Drug
Who makes metoclopramide hydrochloride?
13 companies list metoclopramide hydrochloride as a human prescription drug, including under the names GIMOTI, Reglan. Forms: injection; injection, solution; solution; spray; tablet; tablet, orally disintegrating. Routes: intramuscular, intravenous, nasal, oral.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing metoclopramide hydrochloride
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| Lupin LimitedIndia | tablet, orally disintegrating | ANDAANDA202191 | 2 | 14 |
| Fresenius Kabi USA, LLCUnited States | injection, solution | ANDAANDA091392 | 2 | 6 |
| ANI Pharmaceuticals, Inc.United States | tablet | NDANDA017854 | 2 | 1 |
| PAI Holdings, LLCUnited States | solution | ANDAANDA072744 | 2 | 1 |
| Genus Lifesciences Inc.United States | solution | ANDAANDA072744 | 1 | 2 |
| Henry Schein, Inc.United States | injection | ANDAANDA204756 | 1 | 1 |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.United States | injection | ANDAANDA204756 | 1 | 1 |
| Medical Purchasing Solutions, LLCUnited States | injection | ANDAANDA204756 | 1 | 1 |
| South Atlantic Corporation LLCUnited States | solution | ANDAANDA072744 | 1 | 1 |
| Avenacy, Inc. | injection, solution | ANDAANDA204756 | 1 | 0 |
| Chartwell Governmental & Specialty RX, LLC. | solution | ANDAANDA073680 | 1 | 0 |
| Chartwell RX, LLC. | solution | ANDAANDA073680 | 1 | 0 |
| Evoke Pharma, Inc. | spray | NDANDA209388 | 1 | 0 |
Bulk ingredient listings
- Ipca Laboratories LimitedIndia · 2 NDC
- ASCLEMED USA INC. DBA ENOVACHEMUnited States · 1 NDC
- COSMA SpA · 1 NDC
- Fagron Services B.V.Netherlands · 1 NDC
- ICROM SRLItaly · 1 NDC
- Professional Compounding Centers of America dba PCCAUnited States · 1 NDC
- Spectrum Pharmaceuticals, Inc.United States · 1 NDC
Orange Book patents
7 unexpired patents list metoclopramide hydrochloride as the active ingredient, expiring between Dec 2029 and Nov 2038. Application holder: QOL MEDICAL LLC.
Enquiry
Common questions
- Who makes metoclopramide hydrochloride?
- 13 companies list metoclopramide hydrochloride as a human prescription drug in the openFDA NDC Directory, led by Lupin Limited, Fresenius Kabi USA, LLC, ANI Pharmaceuticals, Inc., PAI Holdings, LLC, Genus Lifesciences Inc.. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic GIMOTI?
- 11 companies list metoclopramide hydrochloride under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies metoclopramide hydrochloride active ingredient?
- 7 companies list metoclopramide hydrochloride as a bulk ingredient, including Ipca Laboratories Limited, ASCLEMED USA INC. DBA ENOVACHEM, COSMA SpA, Fagron Services B.V..