Application Nr Approved Date Route Status External Links
ANDA072801 1993-06-15 Oral RX 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 Recommended 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 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 (3 Total)

Name Structure Kind Function Status
1. Starch, Corn STARCH, CORN Unresolved
2. Calcium Phosphate, Dibasic, Anhydrous CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS Molecular
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.

Active Ingredients ( 1 Total)

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