Application Nr Approved Date Route Status External Links
ANDA078374 2007-11-30 Oral DISCN Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage The Use Of Metoclopramide Tablets Usp Is Recommened For Adults Only. Therapy Should Not Exceed 12 Weeks In Duration. Symptomatic Gastroesophageal Reflux Metoclopramide Tablets, Usp Are Indicated As Short-Term (4 To 12 Weeks) Therapy For Adults With Symptomatic, Documented Gastroesophageal Reflux Who Fail To Respond To Conventional Therapy. The Principal Effect Of Metoclopramide Is On Symptoms Of Postprandial And Daytime Heartburn With Less Observed Effect On Nocturnal Symptoms. If Symptoms Are Confined To Particular Situations, Such As Following The Evening Meal, Use Of Metoclopramide As Single Doses Prior To The Provocative Situation Should Be Considered, Rather Than Using The Drug Throughout The Day. Healing Of Esophageal Ulcers And Erosions Has Been Endoscopically Demonstrated At The End Of A 12-Week Trial Using Doses Of 15 Mg Q.i.d. As There Is No Documented Correlation Between Symptoms And Healing Of Esophageal Lesions, Patients With Documented Lesions Should Be Monitored Endoscopically. Diabetic Gastroparesis (diabetic Gastric Stasis) Metoclopramide Tablets, Usp Are Indicated For The Relief Of Symptoms Associated With Acute And Recurrent Diabetic Gastric Stasis. The Usual Manifestations Of Delayed Gastric Emptying (e.g., Nausea, Vomiting, Heartburn, Persistent Fullness After Meals, And Anorexia) Appear To Respond To Metoclopramide Tablets, Usp Within Different Time Intervals. Significant Relief Of Nausea Occurs Early And Continues To Improve Over A Three-Week Period. Relief Of Vomiting And Anorexia May Precede The Relief Of Abdominal Fullness By One Week Or More.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Starch, Corn STARCH, CORN Unresolved
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Mannitol MANNITOL Molecular NUTR-Nutrient GRAS-Generally recognized as safe.
5. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Metoclopramide Hydrochloride METOCLOPRAMIDE HYDROCHLORIDE ZINC1530716