Active ingredient
Metoclopramide
80 finished FDA listings contain Metoclopramide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- METOCLOPRAMIDE HYDROCHLORIDE
- Dosage forms
- Injection, Injection, Solution, Solution, Spray, Tablet, Tablet, Orally Disintegrating
- Routes
- Intramuscular, Intravenous, Nasal, Oral
- Manufacturers / labelers
- 40
- Strengths listed
- 10 mg/1 · 10 mg/2ml · 15 mg/.07ml · 5 mg/1 · 5 mg/5ml · 5 mg/ml
- Brand names in FDA listings
- Gimoti, Metoclopramide, Reglan
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 6915
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 017854 | ANI PHARMS | 1980-12-30 | 6 |
| ANDA 070184 | TEVA | 1985-07-29 | 19 |
| ANDA 072215 | AIPING PHARM INC | 1990-01-30 | 3 |
| ANDA 073118 | HOSPIRA | 1991-01-17 | 9 |
| ANDA 072744 | PAI HOLDINGS | 1991-05-28 | 4 |
| ANDA 073135 | TEVA PHARMS USA | 1991-11-27 | 3 |
| ANDA 073680 | CHARTWELL MOLECULAR | 1992-10-27 | 2 |
| ANDA 072801 | TEVA | 1993-06-15 | 10 |
| ANDA 071402 | ANI PHARMS | 1993-06-25 | 8 |
| ANDA 078807 | IPCA LABS LTD | 2008-06-12 | 5 |
| ANDA 091392 | FRESENIUS KABI USA | 2013-04-19 | 3 |
| ANDA 204756 | AVET LIFESCIENCES | 2013-12-20 | 4 |
| ANDA 202191 | NOVEL LABS INC | 2014-08-15 | 2 |
| NDA 209388 | QOL MEDCL | 2020-06-19 | 1 |
| ANDA 217072 | BAXTER HLTHCARE CORP | 2026-09-11 | 1 |
Official labeling on DailyMed
- METOCLOPRAMIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] · version 1 · 2026-08-20
- METOCLOPRAMIDE TABLET [REDPHARM DRUG] · version 1 · 2026-08-17
- METOCLOPRAMIDE TABLET [NUCARE PHARMACEUTICALS,INC.] · version 1 · 2026-08-11
- METOCLOPRAMIDE TABLET [REMEDYREPACK INC.] · version 22 · 2026-07-28
- METOCLOPRAMIDE SOLUTION [AMERICAN HEALTH PACKAGING] · version 5 · 2026-07-27
- METOCLOPRAMIDE TABLET [IPCA LABORATORIES LIMITED] · version 4 · 2026-07-15
- METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) SOLUTION [ATLANTIC BIOLOGICALS CORP.] · version 9 · 2026-07-13
- METOCLOPRAMIDE TABLET [PREFERRED PHARMACEUTICALS INC.] · version 6 · 2026-06-26
- METOCLOPRAMIDE TABLET [NUCARE PHARMACEUTICALS, INC.] · version 1 · 2026-06-22
- METOCLOPRAMIDE (METOCLOPRAMIDE HYDROCHLORIDE) INJECTION, SOLUTION [AVENACY, LLC] · version 2 · 2026-06-15
- METOCLOPRAMIDE TABLET [CARDINAL HEALTH 107, LLC] · version 13 · 2026-06-15
- METOCLOPRAMIDE TABLET [COUPLER LLC] · version 1 · 2026-06-03
Showing the 12 most recent of 64 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.